Journal of Tissue Viability (2011) 20, S1eS18

www.elsevier.com/locate/jtv

Review

Evidence-based recommendations for the use

of negative pressure wound therapy in chronic
wounds: Steps towards an international
consensus*
S. Vig a, C. Dowsett b, L. Berg c, C. Caravaggi d, P. Rome e,
H. Birke-Sorensen f, A. Bruhin g, M. Chariker h, M. Depoorter i,
R. Dunn j, F. Duteille k, F. Ferreira l, J.M. Francos Martnez m,
G. Grudzien n, D. Hudson o, S. Ichioka p, R. Ingemansson q,
S. Jeffery r, E. Krug s, C. Lee t, M. Malmsjo u, N. Runkel v,*,
International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP],
R. Martin w, J. Smith x

a
Consultant Vascular and General Surgeon, Croydon University Hospital, London, UK
b
Nurse Consultant, Community Health Newham Directorate, East London NHS Foundation Trust,
London, UK
c
Plastic Surgeon, Kuopio University Hospital, Finland
d
Head, Center for the Treatment of Diabetic Foot Pathology, Istituto Clinico Citta Studi, Milan, Italy
e
Consultant Plastic Surgeon, Royal Prince Alfred and Concord Hospitals, Sydney, Australia
f
Plastic Surgeon, Aleris-Hamlet Hospital, Aarhus, Denmark
g
Consultant Surgeon, Department of Trauma and Visceral Surgery, Luzern, Switzerland
h
Aesthetic Plastic Surgery Institute, Louisville, Kentucky, USA
i
Head of Department of Plastic and Reconstructive Surgery, AZ Sint-Jan AV, Brugge, Belgium
j
Chief, Division of Plastic Surgery, University of Massachusetts Medical School and Memorial Health Care,
Worcester, Mass, USA
k
Head of Plastic, Aesthetic and Reconstructive Surgery e Burn Unit, Hotel Dieu Hospital, Nantes, France
l
General Surgeon, Hospital Pedro Hispano, Matosinhos-Porto, Portugal
m
General Surgeon, Endocrine Surgery Unit, Hospital Universitari de Bellvitge, Barcelona, Spain
n
Cardiac Surgeon, Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital,
Cracow, Poland
o
Head, Department of Plastic and Reconstructive Surgery, Groote Schuur Hospital, Cape Town,
South Africa

*
The information contained within this manuscript was presented in part at an invited Smith & Nephew sponsored symposium
Hamburg February 2010.
* Corresponding author. Postfach 2103, 78011 Villingen-Schwenningen, Germany. Tel.: 49 0 7721 930.
E-mail address: norbert.runkel@sbk-vs.de (N. Runkel).

0965-206X/$36 2011 Published by Elsevier Ltd on behalf of Tissue Viability Society.

doi:10.1016/j.jtv.2011.07.002
S2 S. Vig et al.
p
Professor, Department of Plastic and Reconstructive Surgery, Saitama Medical University, Japan
q
Senior Consultant and Associate Professor in Cardiothoracic Surgery, Department of Cardiothoracic
Surgery, Heart and Lung Division, University Hospital of Lund, Sweden
r
Consultant Plastic Surgeon, The Royal Centre for Defence Medicine, The Queen Elizabeth Hospital,
Birmingham, UK
s
Trauma Surgeon, Leiden University Medical Centre, The Netherlands
t
Assistant Clinical Professor of Surgery (Plastic) at the University of California-San Francisco (UCSF) and
Medical Director of Microsurgery and Wound Care at St.Marys Medical Center, San Francisco, USA
u
Associate Professor and Physician, Department of Ophthalmology, Lund University and Skane University
Hospital, Lund, Sweden
v
Director, Department of General Surgery, Black Forest Hospital, Villingen, and Professor, University of
Freiburg, Germany
w
Clinical Science Program Manager, Smith & Nephew, Hull, UK
x
Clinical Evidence Scientist, Smith & Nephew, Hull, UK

KEYWORDS Abstract Aim: Negative Pressure Wound Therapy (NPWT) has become widely
Negative Pressure adopted over the last 15 years and over 1000 peer-reviewed publications are avail-
Wound Therapy able describing its use. Despite this, there remains uncertainty regarding several
(NPWT); aspects of usage. In order to respond to this gap a global expert panel was convened
Consensus; to develop evidence-based recommendations describing the use of NPWT. In this
Recommendations; communication the results of the study of evidence in chronic wounds including
Systematic review; pressure ulcers, diabetic foot ulcers (DFU), venous leg ulcers (VLU), and ischaemic
Chronic wounds; lower limb wounds are reported.
Pressure ulcers; Methods: Evidence-based recommendations were obtained by a systematic review
Diabetic foot ulcers; of the literature, grading of evidence, drafting of the recommendations by a global
Ischaemic ulcers expert panel followed by a formal consultative consensus development program in
which 422 independent healthcare professionals were able to agree or disagree
with the recommendations. The criteria for agreement were set at 80% agreement.
Evidence and recommendations were graded according to the SIGN (Scottish Inter-
collegiate Guidelines Network) classification system.
Results: The primary treatment goal of NPWT in most chronic wounds is to achieve
wound closure (either by secondary intention or preparing the wound for surgical
closure). Secondary goals commonly include: to reduce wound dimensions, and to
improve the quality of the wound bed. Thirteen evidence based recommendations
were developed in total to address these treatment goals; 4 for pressure ulcers, 4
for DFU, 3 for ischaemic lower limb wounds and 2 for VLU.
Conclusion: The present evidence base is strongest for the use of NPWT in non-
ischaemic DFU and weakest in VLU. The development of evidence-based recom-
mendations for NPWT with direct validation from a large group of practicing clini-
cians offers a broader basis for consensus than work by an expert panel alone.
2011 Published by Elsevier Ltd on behalf of Tissue Viability Society.

Introduction
Negative Pressure Wound Therapy (NPWT) is
a treatment modality that has become widely
adopted for a broad range of wound indications
since its advent over 15 years ago. NPWT is a generic
technology, which can be delivered to a wound using
a range of variables (including source and level of
negative pressure, wound filler and wound contact
layer). Over 1000 peer-reviewed publications
describing the clinical efficacy and safety of NPWT
for all wound types have been published over this
period. The aim of this project was to condense
the existing body of literature into evidence-based
clinical recommendations, which reflect the
strength of evidence in support of each statement.
The present paper covers the use of NPWT in
the treatment of chronic wounds. Further commu-
nications covering other wound types treated with
NPWT have been published elsewhere [1].
In order to develop good quality and robust
recommendations it is important that the
Negative pressure wound therapy in chronic wounds S3

In addition to developing recommendations, the

Abbreviations panel sought to clarify treatment goals that can be
achieved using NPWT. It is increasingly recognized
ABI ankle brachial index that NPWT can be used to achieve a variety of
CLI critical limb ischaemia treatment goals, which will vary according to the
DFU diabetic foot ulcer patient and wound characteristics. The advent of
L1eL4 evidence level 1 (highest) to 4 NPWT has introduced the concept that treatment
(lowest) goals other than wound healing may in themselves
NPUAP national pressure ulcer advisory be useful end-points in clinical practice. In addi-
panel tion to developing evidence-based recommenda-
NPWT negative pressure wound therapy tions, the intention of this project was to clarify
NPWT-EP negative pressure wound therapy the appropriate goals for different wound types.
expert panel
PVD peripheral vascular disease
RCT randomized controlled trial Methods
SIGN Scottish intercollegiate guidelines
network This study adopted a novel approach by combining
STSG split thickness skin graft a formal consensus development program involving
TNP topical negative pressure consultation with 422 independent healthcare
VAC vacuum-assisted closure professionals with a formal evidence-based medi-
VLU venous leg ulcer cine activity (i.e. full systematic review of the
literature). The recommendations presented here
recommendations are developed by, and in consul- have undergone extensive consultation with
tation with, experts who are vigorously active in the healthcare professionals and peer review as
practice of medicine. The development of recom- a requirement of publication.
mendations from a purely academic perspective
would lead to gold standard recommendations, Systematic literature review
which may represent theoretical clinical practice but
may be difficult to apply to real life clinical settings A series of systematic searches (PubMed) were
[2]. The intention of these recommendations is that carried out by one of the authors (JS) (updated in
they avoid bias from any particular manufacturer of January 2011) using the following search terms:
NPWT. In order to achieve this goal, generic termi- (NPWT OR negative pressure OR VAC OR vacuum-
nology has been used throughout without reference assisted OR TNP) AND [one of the following];
or limitation to any specific manufacturer of NPWT pressure ulcer; (diabetic foot ulcer OR DFU OR
products. A panel of clinical experts in NPWT (NPWT- diabetic foot); (leg ulcer OR VLU); (revascu-
EP) was established with representation from larisation OR revascularization). Searches were
a variety of disciplines and from many countries limited to studies published after 1996 (when
around the world. The panel also sought validation of modern formats of NPWT became commercially
the principle recommendations during a formal available). Results are shown in Table 1. One search
consultative phase with 422 independent healthcare was obtained for each indication and reviewed
professionals during a global symposium to further separately. Titles and abstracts of all studies were
dilute any potential source of bias. reviewed for relevance and cross-referenced where

Table 1 Results of the systematic searches.

Pressure ulcers DFU VLU Lower limb ischaemia
Papers identified 81 102 38 64

Reasons for exclusion Not related to NPWT 6 11 2 18

Aetiology out of scope 22 17 6 24
Broad scope reviews 15 21 9 3
Not humana 1 0 0 1

Papers reviewed 37 53 21 18
This list was supplemented by relevant studies from other sources.
a
In vivo and in vitro studies were reviewed where they were of particular relevance.
S4 S. Vig et al.

necessary into the other sections, especially where
studies on mixed cohorts of patients were involved.
These searches were supplemented where appro-
priate by literature identified by other means.
All selected papers were assessed against the
following criteria before being identified for further
review (Table 1): studies where end-points relevant
to NPWT were not reported or where the use of
NPWT was incidental to other therapies/techniques
under investigation (not related to NPWT) and
papers reporting irrelevant clinical indications
(aetiology out of scope) were excluded. This
heading was also used to exclude studies not
involving approved indications for NPWT products.
Broad scope reviews and letters to the editor were
excluded (reviews specific to the relevant indica-
tion were included). In vitro and in vivo studies were
excluded except in exceptional circumstances
when the data was particularly relevant. Studies
focussing on a specific aetiology, or where a specific
aetiology made up a significant proportion (>70%) of
the patient numbers were considered more relevant
than studies containing a variety of wound aetiol-
ogies. While studies in all languages were consid-
ered, for relevant papers in languages other than
English, only information contained in the abstract
was reviewed. All relevant studies were reviewed
regardless of the number of patients, type of study
or method of delivery of NPWT being reported.
Development of recommendations
The recommendations described in this report
were determined during a series of meetings
between the members of the NPWT expert panel
over 6 months. Recommendations were developed
according to a modification of the SIGN (Scottish
Intercollegiate Guidelines Network) classification
system [2]. Table 2 describes the classification of
the levels of evidence used and the corresponding
strength of recommendation that can be made
from each evidence level. Evidence levels were

Table 2A Translation of levels of evidence to graded recommendations.

Recommendation
Grade Terminology Description
A MUST At least one meta-analysis, systematic review, or RCT rated as 1, and directly
applicable to the target population; or
A body of evidence consisting principally of studies rated as 1, directly applicable
to the target population, and demonstrating overall consistency of results
B SHOULD A body of evidence including studies rated as 2, directly applicable to the target
population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1 or 1
C MAY A body of evidence including studies rated as 2, directly applicable to the target
population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2
D POSSIBLE Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2
Adapted from the SIGN method of classification [2]. Modification was made by using specific terminology to clarify the strength of
each evidence-based recommendation (Must for grade A, Should for grade B, May for Grade C).

Table 2B Evidence level.

Level Description
1 High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1 Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias
1 Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2 High quality systematic reviews of case control or cohort studies. High quality case control or cohort
studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2 Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate
probability that the relationship is causal
2 Case control or cohort studies with a high risk of confounding or bias and a significant risk that the
relationship is not causal
3 Non-analytic studies, e.g. case reports, case series, in vivo or in vitro studies
4 Expert opinion
Adapted from the SIGN method of classification.
Negative pressure wound therapy in chronic wounds S5

identified in the text as outlined in Table 2B and
referred to as Level (L) 1e4 as appropriate.
Modification to the SIGN guidelines was made
by using specific terminology to clarify the
strength of each evidence-based recommendation
(Must for grade A, Should for grade B, May for
Grade C).
A separate series of recommendations were
developed for each specific clinical indication.
A series of treatment goals were defined for
each indication consistent with the recommen-
dations. The treatment goals are shown in
Table 3.
Formal consensus development
Formal consensus techniques were then used to
gain consensus on the recommendations in a two-
stage process. Firstly during the development
phase, consensus was obtained between the
Expert Panel members. At this stage, the recom-
mendations were modified until 100% agreement
amongst the panel members was obtained. The
second phase of consensus development consisted
of a consultative phase; the principle recommen-
dations were presented in an international NPWT
meeting (Hamburg, February 2010) to an invited
audience of 422 healthcare professionals from 29
countries (comprising 69% surgeons and 31% other
clinicians. Appendix 1 gives further details).
Finally, for the majority of recommendations, the
entire audience voted using interactive handsets
(manufactured by Turning Point, UK) on whether
they agreed or disagreed with the proposed
recommendations. Some recommendations were
voted on (also using the interactive handsets) by
a smaller breakout group of approximately 100
clinicians (as indicated). Strength of the consensus
was indicated as the percentage of voting partici-
pants who agreed with the recommendation. Lack
of consensus (<80% agreement) was generally
considered an indicator of varied clinical practice
along with insufficient published clinical evidence
and signified a potential evidence gap.
NPWT and chronic wounds
NPWT is commonly used to treat chronic wounds,
especially those that have been non-respondent to
alternative therapies [3]. The following issues,
which influence the use of NPWT relate equally to
all types of chronic wounds:
NPWT can be used with different clinical goals in
mind: either as a bridge to surgical closure or to
progress to wound closure by secondary intention.
Progression by secondary intention is chosen for
a variety of reasons including lack of access to
surgical closure (for example in an out-patient
setting), patient choice, unsuitability of the
patient for surgery, or unsuitability of the wound to
receive surgical closure. One potential disadvantage
of using NPWT to complete closure by secondary
intention is the impact of the protracted duration of
NPWT on patient quality of life. This is a particular
issue in the treatment of chronic wounds as time to
healing, especially healing by secondary intention,
may take longer than in many acute indications.
NPWT, while theoretically portable and suitable for
home-care, may be noisy, prevent patients from
sleeping, be heavy to carry, or make them self-
conscious about their therapy. The quality of life of
previously ambulatory patients has been shown to
decrease upon application of NPWT [4].
Another general issue when considering the
application of NPWT to a chronic wound is the
need for debridement. NPWT cannot be considered
a substitute for thorough debridement and is
contra-indicated in wounds which contain necrotic
tissue. A thorough wound debridement prior to

Table 3 Treatment Goals for application of NPWT.

Goals Indications
Pressure ulcers DFU VLU Lower Limb Ischaemia
To achieve wound closure (by secondary C C C B
intention or surgical closure)
To reduce complexity/size of wound B B B
To Improve patient quality of life B B B B
To manage wound fluid and oedema B B B
To prevent wound deterioration B C

Although NPWT is a treatment that operates simultaneously through multiple actions, in order that specific recommendations
could be made and voted on, a single overarching treatment goal was selected as part of the consensus process. The clinical
benefit clearly derives from the combination of all of the treatment goals.
Closed circles indicate the primary goal and open circles indicate secondary goals within each indication.
S6 S. Vig et al.

application is recommended in all chronic wounds
that contain necrotic or non-viable tissue.
Several other issues are specific to individual
chronic indications. A range of recommendations
were developed and are presented below accord-
ing to individual wound etiologies.
Use of NPWT in pressure ulcers
Generally it is agreed that NPWT is suitable only
for grade 3 and 4 pressure ulcers [5]. Optimisation
of both the patient and the wound is also imper-
ative before NPWT can be considered [6,7]. This
means stabilization and treatment of any under-
lying co-morbidity, nutritional assessment and
appropriate pressure relief must be initiated,
along with the need for vascular assessment in the
case of extremity ulcers [5]. The recommendations
below assume that the best care and patient
optimization has taken place, leaving a pressure
ulcer with the best possible opportunity to heal.
The primary treatment goal for the application
of NPWT to pressure ulcers is to achieve wound
closure (either by surgical or secondary intention).
Secondary goals include: to reduce the size of the
defect, to improve the quality of the wound bed
and to improve patient comfort (Table 3). In some
patients, the application of NPWT may be appro-
priate for palliative reasons, to avoid frequent
dressing changes, prevent contamination from
faeces, reduce odour and to manage wound
exudate. This is in accordance with other
commentators [6].
Recommendation: NPWT may be used until
surgical closure is possible/desirable. Grade C;
Agreement in consultative phase 99% (voting
data from breakout session); Table 4.
As long as both the wound and the patient are
suitable candidates for surgery, it may be most
appropriate to surgically close a grade 3 or 4 pres-
sure ulcer. This is in accordance with other
commentators [6,7]. The benefits include a less
protracted duration of healing, thereby reducing
the longer term burden of care. However, disad-
vantages include morbidity of tissue donor sites,
which in a patient with reduced capacity for heal-
ing, may become problematic. Nakayama et al. [8]
suggest that the size of the wound may influence
suitability of the wound for surgical closure. They
reported that wounds measuring over 20 cm2 were
closed with either a skin graft or a musculocuta-
neous flap, whereas smaller wounds were allowed
to close by secondary intention, with NPWT applied
as an adjunct.
Pressure ulcer wounds often require a period of
wound bed preparation prior to surgical closure to
improve the quality of the wound bed and improve
the chance of success. NPWT has been reported to
be a useful tool in this stage of the process (L1:
[9,10], L3: [8,11e13]) No compelling evidence
exists to suggest that NPWT increases the speed of
healing in pressure ulcer wounds. Ford et al. [10]
in a small RCT reported no significant reduction
in wound volume compared with the comparator (a
three part combination therapy referred to as the
Healthpoint system). In comparison with conven-
tional dressings, Wanner et al. [9], reported the
duration of therapy required to reduce the size of
the pressure ulcer defect by 50% thus allowing flap
closure. No significant difference between the
wounds treated with NPWT and those treated
with conventional wet-to-dry gauze dressings
were observed (27 and 28 days respectively).
Application of NPWT has other advantages
including improved exudate management, reduced

Table 4 Evidence-based recommendations for the use of NPWT in pressure ulcers.

Treatment goal Recommendation and grade (AeD) Supporting reference and
evidence level (1e4)
Primary goal: NPWT may be used until surgical C L1: [9,10]
To achieve wound closure closure is possible/desirable L3: [8,11e13]
Alternatively, NPWT should be B L1: [14]:
considered to achieve closure L2: [15]:
by secondary intention. L3: [16e19]:

How goal is achieved NPWT should be used to reduce B L1: [10,20]

wound dimensions L2: [21]
L3: [16,18,19,22,23]
NPWT should be used to improve B L1 [10,20,24]:
the quality of the wound bed L3: [8,11,16,25]
Negative pressure wound therapy in chronic wounds
frequency of dressing changes affecting positively
on patient comfort and improved costs [9].
Recommendation: Alternatively, NPWT should
be considered to achieve closure by secondary
intention. Grade B; Agreement in consultative
phase 89%; Table 4.
Although several studies reporting outcomes on
pressure ulcers describe a mixture of patients
healed by surgical closure and secondary inten-
tion, several show a greater prevalence of wounds
healed by secondary intention healing (L1: [14],
L3: [15e19]). Mody et al. [14] (L1) reported
outcomes of a subset of pressure ulcers and
observed a significantly faster time to closure by
secondary intention in the NPWT group compared
with the standard gauze group (10 and 27 days
respectively).
Evidence to support the adoption of NPWT as
a first line therapy in the treatment of stages 3 and
4 pressure ulcers for healing by secondary inten-
tion in the home-care setting was presented by
Baherestani et al. [15]. They described that in the
provision of home health care, carers are often
obliged to demonstrate that other therapies have
not been effective in order to obtain reimburse-
ment for NPWT. This results in a significant delay
before NPWT becomes available. In this study,
early initiation of NPWT (within 30 days) was
associated with shorter requirement for home
health care for Stage III or Stage IV pressure ulcers
or surgical wounds compared with late initiation of
therapy (>30 days) (86 vs 166 days respectively).
This suggests that earlier adoption of NPWT may
improve the rate of healing by secondary inten-
tion, providing significantly reduced treatment
time and cost benefits, which is consistent with
guidelines presented by the National Pressure
Ulcer Advisory Panel (NPUAP) [5]. How these
outcomes compare with hospital based surgical
closure of pressure ulcers has not been investi-
gated. However, in patients where surgical closure
is not an option, early NPWT to achieve secondary
closure is recommended over conventional
therapy.
Recommendation: NPWT should be used to
reduce wound dimensions. Grade B; Agreement in
consultative phase 94%; Table 4.
One benefit that NPWT can provide in achieving
either healing by secondary intention or prepara-
tion for surgical closure is the reduction of wound
dimensions. Progression towards closure by
secondary intention is, by definition, driven by
a reduction in wound dimensions. While surgical
closure is not entirely dependent on a reduction in
S7
the size of the defect, the benefit of reducing
wound size is that smaller and less complex
reconstructive approaches can be adopted if
a reduction in wound size is achieved with result-
ing lessening impact on patient morbidity. For
example, use of NPWT may reduce wound dimen-
sions and complexity so that wounds previously
only suitable for a flap procedure may be con-
verted to ones suitable for closure by a simpler
surgical procedure instead.
Many studies have reported end-points related
to reduction in pressure ulcer dimensions
(L1: [10,20], L2: [21], L3: [16,18,19,22,23]). Ford
et al. [10] (L1) reported a randomized
controlled trial (RCT) comparing NPWT with
a comparator combination therapy (Healthpoint
system). The reduction in pressure ulcer volume
of 51.8% with NPWT was significantly greater than
with the comparator over a 6-week study period.
In a second study, Joseph et al. [20] (L1-)
observed significant reductions in dimensions in
pressure ulcers treated with NPWT compared
with saline gauze alone, the most striking of
which was an overall reduction in wound depth
and volume of 66% and 78% respectively, over
a study duration of 6 weeks. Both values were
significantly improved compared with the saline
gauze comparator arm.
Philbeck et al. [21] in a retrospective review of
Medicare records compared with equivalent data
from the literature, reported a significantly faster
closure rate per day in the NPWT group compared
to a historic control (0.23 cm2 and 0.09 cm2 per
day respectively). These reported improved rates
of wound reduction are not supported by Wanner
et al. [9] (L1) (described above).
Recommendation: NPWT should be used to
improve the quality of the wound bed. Grade B;
Agreement in consultative phase 95%; Table 4.
In the preparation of wounds for surgical closure
by flap or graft, a reduction in wound size may be less
important than the achievement of a good quality
wound bed. NPWT is not considered a substitute for
thorough debridement and the importance of
debridement, especially of necrotic tissue cannot be
underestimated. However, following removal of
necrotic and non-viable tissue, wound beds may still
require some further preparation in order to maxi-
mize the chances of successful surgical closure. The
ability of NPWT to generate granulation tissue is
widely recognised and is considered a key benefit of
the therapy and has been reported in several pres-
sure ulcer studies. Ford et al. [10] reported the
results of an RCT comparing NPWT with a comparator
combination therapy (Healthpoint system). The
S8 S. Vig et al.

quality of the granulation tissue formed was assessed
by blinded histological assessment of the density of
newly formed capillaries and was significantly
greater in the NPWT group compared with the
control. Wild et al. [24] reported an RCT comparing
NPWT with Redon drains and reported an increase in
surface granulation tissue of 54% in the NPWT group,
compared with a reduction in the Redon group. The
principle characteristic of wounds treated by NPWT
in Joseph et al. [20] was observed histologically to be
granulation tissue formation. The data presented in
some of these studies may be of limited value
because of the inclusion of unfamiliar comparator
arms. However they do demonstrate a positive effect
of applying NPWT. Several level 3 studies have
observed the generation of granulation tissue
following the application of NPWT to pressure ulcers
[8,11,16,25].
The use of NPWT in diabetic foot ulcers
NPWT can be used to treat a range of wounds asso-
ciated with diabetic lower limb disease and NPWT
has been reported in a survey of vascular surgeons to
be most commonly used for this purpose [3]. NPWT
can be applied to a chronic recalcitrant DFU and also
wounds in the diabetic limb following surgical
debridement or partial amputation. Several
commentators have proposed the incorporation of
NPWT into an integrated surgical protocol, consist-
ing of radical surgical debridement to remove
necrotic tissue (or partial amputation depending on
the extent of the necrosis) followed by NPWT to
reduce wound dimensions and improve the quality
of the wound bed [26,27].
The primary treatment goal in the application of
NPWT to DFU is to progress a wound towards
closure either by secondary intention or surgical
closure (Table 3). When determining the treat-
ment goal for an individual DFU (whether to aim
for closure by secondary intention or surgical
closure) a useful benchmark was presented by
Lavery et al. [28]: early wound progression
following application of NPWT was used to predict
the likelihood of successful healing by secondary
intention at 16 weeks. Wounds that had reached
a 15% reduction in wound area after one week or
60% reduction after four weeks of NPWT had a 68%
and 77% probability (respectively) of future heal-
ing with NPWT. The probability of future healing
with NPWT was 31 and 30% (respectively) if these
wound area reductions were not achieved at these
early stages. Secondary goals are: to reduce the
risk of amputation (as part of an integrated
medical and surgical approach), to achieve faster
wound bed preparation and to reduce the
frequency of dressing changes (Table 3).
The vast majority of published studies regarding
DFU describe results following NPWT in adequately
perfused limbs. Application of NPWT to lower limb
wounds with significant ischaemia will be discussed
in more detail in a subsequent section. For the
purposes of this section, discussion is limited to
diabetic lower limb disease with adequately
perfused tissue.

Table 5 Evidence-based recommendations for the use of NPWT in diabetic foot ulcers.
Treatment goal Recommendation and grade (AeD) Supporting reference and
evidence level (1e4)
Primary goal: NPWT must be considered as an advanced A L1: [30,31,42]
To achieve wound closure wound care therapy for postoperative L2: [33]
Texas Grade 2 and 3 diabetic feet L3: [26]
without ischaemia
NPWT must be considered to achieve A L1: [30,31]
healing by secondary intention. L3: [26,27]
L4: [34]

Alternatively NPWT should be stopped B L1: [30a 31, 32a, 38a]

when wound has progressed suitably to L3: [44e48]
be closed by surgical means

To prevent wound NPWT should be considered in an attempt B L1: [30,31]

deterioration to prevent amputation or re-amputationb L2: [39]
L3: [26,56,57]
L4: [34]
a
Data extrapolated from this study supports the recommendation indirectly.
b
Recommendation not voted on in consultative phase.
Negative pressure wound therapy in chronic wounds
Recommendation: NPWT must be considered as
an advanced wound care therapy for post-
operative Texas Grade 2 and 3 diabetic feet
without ischaemia. Grade A; Agreement in
consultative phase 88%; Table 5.
The University of Texas Grading system [29] has
been shown to be more sensitive than the alter-
native Wagner system in predicting outcomes and
has therefore been adopted here. There is
considerable evidence that application of NPWT to
moderate to severe DFUs is beneficial. This would
equate with Texas Grade 2 (penetrating to capsule
or bone) and 3 (penetrating to bone or deep
abscess). There is in general an improved chance
of faster healing with a grade 1 DFU (superficial
ulceration) and hence application of NPWT may
not be immediately warranted in these wounds
[29]. Application of NPWT onto an ischaemic DFU
(Texas grade 2c, 2d, 3c and 3d) is a different
clinical scenario and is discussed in more detail in
a subsequent section.
NPWT has been demonstrated in numerous
comparative studies to offer a range of advantages in
the treatment of diabetic foot ulceration compared
with conventional therapy (most commonly, saline
gauze alone). Improvements compared with
conventional therapy, in time to healing (L1:
[30e32], L2: [33], L4: [34]), cost of treatment (L1:
[35], L2-: [36], L2: [33,37], L4: [34]), speed of gran-
ulation tissue formation (L1: [30e32,38]), lower
amputation rates (L1: [30,31], L2: [39], L4: [34]),
faster decrease in wound dimensions (L1: [31,32,40])
have all been reported with no detrimental effects
on the rate of complications or adverse events (L1:
[30,31], L2: [41]).
It may be that certain patient demographics or
wound types may benefit more significantly from
application of NPWT than others. Lavery et al. [36]
(L2-) identified a correlation between the number
of successful wound outcomes and initial wound
size for wet-to-dry gauze-treated wounds. Larger
wounds were less likely to achieve a positive
outcome at both 12 and 20 weeks of therapy.
Treatment with NPWT not only improved the rate
of successful outcomes compared to wet-to-dry
gauze but when NPWT was used, there was no
correlation between outcomes and wound size
suggesting that larger wounds may respond better
if treated with NPWT.
Several studies have investigated whether the
duration of the wound prior to therapy impacts on
the efficacy of NPWT. Armstrong et al. [42] repor-
ted no difference in outcomes of acute (<30 days)
or chronic (>30 days) diabetic wounds treated
with NPWT. However, a more detailed stratification
S9
reported by Lavery et al. [36] (L2-) suggested that
wound duration may have an impact on outcomes.
In this study wounds of a longer duration (>1 year)
treated with saline gauze tended to have poorer
outcomes following 20 weeks of therapy than those
with shorter durations. This trend was less apparent
in wounds treated with NPWT. In addition, wounds
of greater than one year in duration had signifi-
cantly improved outcomes if treated with NPWT
compared with saline gauze-treated wounds of the
same duration. These studies, while accepting that
wounds of longer duration have a more significant
barrier to healing, suggest that in wounds of greater
than one year duration, significant advantage
may be realized by application of NPWT compared
with continuing with conventional (saline gauze)
therapy.
Recommendation: NPWT must be considered to
achieve healing by secondary intention. Grade A;
Agreement in consultative phase 96%; Table 5.
Several publications favour closure by secondary
intention of diabetic foot wounds (L1: [30,31], L2:
[33], L3: [26,27,43], L4: [34]). NPWT has been shown
to significantly improve the rate of wound closure by
secondary intention compared with saline gauze
alone (L1 [30,31]). In both of these studies the
majority of patients were progressed by secondary
intention with only a minority of wounds closed
surgically. In the seminal Armstrong and Lavery paper
[30] significantly more patients healed in the NPWT
group than in the saline gauze control group (56%
compared with 39% respectively) within the 112-day
study period. The median time to closure in patients
treated with NPWT was 56 days. In a larger study of
similar design, 43% of patients treated with NPWT
achieved a complete ulcer closure compared with
only 29% of patients treated with conventional
therapy within the 112-day study duration [31]. The
Kaplan Meier estimate of the median duration of
complete closure was calculated as 96 days for
NPWT, significantly faster than with the control (not
determinable). There are several disadvantages of
treating DFUs to complete wound closure using
NPWT, including the relatively protracted treatment
period expected and the impact this has on both the
patients quality of life and the overall cost of
therapy. In clinical practice, NPWT is often used to
significantly reduce the dimensions of the wound
before progressing to alternative advanced wound
management methods.
Supporting the benefit of NPWT in reducing time
to healing by secondary intention in DFUs are
a series of RCTs, which report a significantly faster
decrease in wound dimensions in wounds treated
with NPWT compared with conventional treatment
S10
(L1: [31,32,40]). Wound depth, area and volume
have all been reported to be significantly reduced
in NPWT-treated wounds compared with the
conventional therapy [31,32,40].
Recommendation: Alternatively NPWT should
be stopped when wound has progressed suitably to
be closed by surgical means. Grade B. Agreement
in consultative phase 96%; Table 5.
Several commentators favour the closure of DFU
using NPWT as a bridge to achieve surgical closure
(L1: [32], L3: [44e48]). Granulation tissue forma-
tion is critical to ensure successful surgical
closure. NPWT increases the speed of granulation
tissue formation (L1: [30e32,38]) and may there-
fore contribute to the speed in which a wound
becomes a good candidate for surgical closure.
This may impact on the number of hospital bed
days required to complete treatment and may
influence the cost of therapy significantly.
Recommendation: NPWT should be considered
in an attempt to prevent amputation or re-
amputation, Grade B; Table 5. Not voted on in
consultative phase.
Failure to heal in a DFU can often lead to
deterioration and minor or major amputation.
Major amputations in particular, have a devas-
tating impact on the patient including increased
morbidity and mortality [49e52], reduced quality
of life [53,54], and high healthcare costs [55].
Several studies have reported that NPWT
reduces the incidence of amputation (L1: [30,31],
L2: [39], L4: [34]). Blume et al. [31] compared the
treatment of DFU with either NPWT or saline gauze
and reported a significantly lower rate of minor
and major amputation in the NPWT group.
Armstrong and Lavery [30] compared the
treatment of diabetic foot wounds following
partial foot amputation with either NPWT or moist
wound therapy and reported a reduced rate of re-
amputation (3% compared with 11% respectively)
in the NPWT group. Although the difference was
not significant, the relative risk ratio indicated
that patients treated with NPWT were four times
less likely than control patients to be in need of
a second amputation. There was also some
evidence that the use of NPWT limited the severity
of the re-amputation with more above-knee
amputations in the control group.
Frykberg et al. [39] (L2) retrospectively ana-
lysed data obtained from two data sources (Medi-
care and commercial payers) and calculated a 35%
and 34% reduction in amputation rates respectively
in wounds treated with NPWT compared with
conventional therapies. As a means of standardising
S. Vig et al.
wound severity between control and NPWT-treated
groups, the depth of debridement procedures
undertaken were assessed (none, skin, muscle,
bone). In wounds treated with conventional
therapy, the rate of amputation increased as the
depth of a debridement procedure deepened:
debridement to bone was more strongly linked to
a subsequent need for an amputation procedure.
Fifty three percent of wounds debrided to bone and
subsequently treated by conventional therapies,
required an amputation. However in wounds debri-
ded to bone and subsequently treated with NPWT,
only 18% of patients required an amputation (Medi-
care data) [39]. This data suggests that in diabetic
foot wounds requiring deep debridement down to
bone, there may be significant benefit in the treat-
ment of the resulting wound with NPWT in order to
prevent the need for further amputation. These
findings are supported by a number of L3 studies
reporting low incidence of amputation rates in lower
limb diabetic wounds treated with NPWT [26,56,57].
Use of NPWT in wounds of the ischaemic
lower limb
The use of NPWT on wounds in the ischaemic limb
is a highly specialised clinical scenario. Adequate
blood perfusion is necessary to support the nutri-
tional and metabolic requirements of tissue. If
blood perfusion is reduced, often as a result of
systemic disease such as peripheral vascular
disease (PVD), the nutritional and metabolic
requirements of the tissue are not met and tissue
viability is compromised. Severe PVD can lead to
critical limb ischaemia (CLI) resulting in loss of
tissue viability often manifested as ulceration. In
the absence of adequate blood perfusion, normal
wound healing processes cannot proceed [58].
Limb ischaemia, defined as rest pain, ulcers, or
tissue necrosis attributed to arterial occlusive
disease can be described as either acute (rapid
onset with symptoms present for less than two
weeks) or chronic (gradual onset with symptoms
present for more than two weeks) [59]. Ankle
brachial Index (ABI) of less than 0.9 is indicative of
ischaemia and less than 0.5 indicates CLI. An
alternative measure is perfusion pressure of less
than 30 mmHg. The urgency and type of treatment
varies depending on whether the patient is
suffering acute or chronic ischaemia. Guidelines
on the management of acute and chronic
ischaemia have been published elsewhere [59,60].
Revascularisation (where possible) is without
doubt the best intervention to achieve limb
salvage in patients with either acute or chronic
Negative pressure wound therapy in chronic wounds S11

lower limb ischaemia and its importance as a first
line therapy where possible, cannot be under-
estimated. However there are circumstances in
both acute and chronic limb ischaemia where
revascularisation procedures are either not
appropriate or successful. In these circumstances,
alternative approaches to wound management,
including NPWT, may be considered.
The application of NPWT onto exposed organs,
exposed vasculature or anastomotic sites is contra-
indicated [61]. Although the use of NPWT on sites
of exposed, infected vascular grafts is relatively
common in the literature, NPWT treatment of
these types of wounds are contra-indicated and
are not discussed here.
Recommendation: The cautious use of NPWT in
chronic limb ischaemia when all other modalities
have failed may be considered in specialist hands
and never as an alternative for revascularisation.
Grade C; Agreement in consultative phase 92%;
Table 6.
The most common underlying pathology leading to
chronic limb ischaemia is PVD which can progress to
critical limb ischaemia (CLI). Therapeutic goals in
treating patients with CLI include reducing cardio-
vascular risk factors, relieving ischaemic pain, heal-
ing ulcers, preventing major amputation, improving
quality of life and increasing survival. These aims
cannot all be met by the application of NPWT but
depend primarily on a combination of medical
intervention (including pharmaceutical control of
underlying disease, pain and thrombolysis) and
revascularization to restore blood flow. However, in
up to 14% of patients surgical or endovascular
procedures are not recommended for clinical or
technical reasons [62]. Revascularisation techniques
will also fail in a significant proportion of procedures:
a meta-analysis revealed that, in terms of primary
patency at one month post-surgery, 33% of angio-
plasty and 7% of bypass procedures were unsuccess-
ful [63]. When efforts to revascularise the limb have
failed or are not possible, further effort should be
made to salvage the limb through aggressive wound
management. It has been shown that the majority of
limbs with CLI, not suitable for revascularisation, can
be salvaged [62], indicating that immediate
progression to amputation is only warranted in
extreme circumstances. The cautious use of NPWT in
chronic limb ischaemia as part of an aggressive
wound management protocol may be considered
with the goal of preventing amputation. NPWTshould
not be considered a substitute for revascularization
procedures, infection control or for surgical
debridement of necrotic tissue [64,65]. It must also
be acknowledged that no treatment will guarantee
that amputation can be avoided and that careful
monitoring of these wounds is of critical importance.
The involvement of a vascular specialist to confirm
that all other possible treatment options have been
considered is strongly recommended given the
challenging nature of these wounds.
Several L3 studies [43,66,67] report healing
outcomes in patients with chronic lower limb
ischaemia in the absence of successful revasculari-
zation. Clare et al. [43] (L3) reported that six of eight
wounds with severe PVD healed completely following
NPWT. Horch et al. [66] (L3) reported a series of 21
patients with CLI all of whom successfully received
a STSG following NPWT. Vuerstaek et al. [68] (L1)
reported a RCT of a mixed group of lower limb ulcers,
over half of which had an arterial component to them
(with ABI values as low as 0.6). Although it is not
possible to separate out the results of the venous leg
ulcers from the arterial ulcers and arteriosclerotic
ulcers, overall a significant decrease in the time
taken to prepare the wound bed for subsequent graft
procedure, and a shorter overall time to healing was

Table 6 Evidence-based recommendations for the use of NPWT in ischaemic lower limb wounds.
Treatment goal Recommendation and grade (AeD) Supporting reference
and evidence level (1e4)
Primary goal: The cautious use of NPWT in chronic limb ischaemia C L1: [68]a
To prepare for surgical closure when all other modalities have failed may L3: [43,66,67]
be considered in specialist hands but never
as an alternative for revascularisation.
NPWT may be considered as an advanced wound D L3: [64,71e73]
care therapy for lower limb ulceration after L4: [3,73]
revascularisation

Caution The use of NPWT is NOT indicated in D Expert opinion

acute limb ischaemiab
a
Data extrapolated from this study as study population was composed of a mixture of lower limb ulcer aetiologies.
b
Recommendation not voted on in consultative phase.
S12
observed in wounds treated with NPWT as opposed to
conventional therapy.
The rate of granulation tissue formation has
been reported to be slower than would be expec-
ted for acute, non-ischaemic wounds at six to 14
days, it therefore may not be appropriate to assess
the wound for progression towards healing any
sooner than one week of therapy [66]. Dressing
changes should however be carried out every two
to three days as a minimum to ensure that there is
no deterioration of the wound.
A significant barrier to understanding the
impact of NPWT on wound healing in chronic limb
ischaemia is the lack of data presented relating to
the severity of the ischaemic disease, in particular
ABI, which is otherwise a widely reported metric.
The high incidence of limb salvage and graft
success in the studies discussed above may be
unremarkable if their underlying disease in the
reported study was relatively mild.
NPWT may also be of benefit following surgical
closure, in bolstering a STSG to the prepared
ischaemic wound surface to encourage good graft
take [66,69,70]. Repeat graft procedures may be
necessary [66], indicating that to achieve stable
closure in these challenging wounds, a degree of
perseverance is expected.
A significant proportion of patients with chronic
limb ischaemia may be expected to fail to achieve
surgical closure and will require amputation. Very
little analysis has been done to identify those most at
risk of failure. However, in studies where NPWT was
used as an adjunct to achieve surgical closure, dia-
betes and a history of failed revascularization have
been observed as factors which may predispose
a patient to fail [43]. Other factors which are likely to
be important include disease severity, often
measured as ABI [62]. It is important to acknowledge
that where the underlying pathology is not addressed,
there is likely to be a higher chance of recurrence.
Recommendation: NPWT may be considered as
an advanced wound care therapy for lower limb
ulceration after successful revascularisation.
Grade D; Agreement in consultative phase 94%;
Table 6.
NPWT may be considered in a postoperative
wound in a vascular patient if sepsis has been
controlled, if underlying structures have been
assessed and ideally as a treatment initiated and
assessed by a vascular specialist. In a New Zealand
survey of vascular surgeons, Laney et al. [3]
reported that 24% often use NPWT and a further
59% sometimes use NPWT on revascularised arte-
rial ulcers, indicating a high degree of adoption of
NPWT in this wound type.
S. Vig et al.
Aust et al. [71] reported a case series of 34
patients with limb ischaemia who underwent
revascularisation prior to surgical closure of their
chronic wound resulting in improved perfusion of
their wound. NPWT was applied in 15 of these
cases with good outcomes observed. Rivolta et al.
[64] (L3) reported 3 cases where NPWT was used to
heal minor amputation stumps following revascu-
larisation with good healing outcomes. Lejay et al.
[72] (L3) reported a series of 14 patients who
required revascularisation in support of a non-
healing ulcer and reported an 87% healing rate
following NPWT. Nishimura [73] (L3) reported
a single case where good resolution of the wound
after toe amputation was observed following
revascularisation procedures. Inaba et al. [74] (L4)
suggested that NPWT is appropriate following
revascularisation surgery in patients with CLI.
Recommendation: The use of NPWT is NOT
indicated in acute limb ischaemia. Grade D; Not
voted on in consultative phase; Table 6.
Acute Limb Ischaemia (ALI) results from
a blockage of an arterial supply to the extremity,
leading to rapid onset of symptoms including sudden
pain, muscle weakness and sensory loss. The two
most common causes for acute limb ischaemia are
embolus and thrombosis secondary to underlying
disease such as atherosclerosis. The severity of the
ALI is graded and divided into salvageable (grade 1
and 2) and unsalvageable (grade 3). Typically, those
limbs which present with necrotic tissue are at an
advanced stage of ischaemia, are unsalvageable
and will progress to amputation [59,60]. Up to 30% of
patients who present with ALI will progress to
amputation because the viability of the distal tissue
has been severely compromised and the limb is
unsalvageable [75]. Attempts at limb salvage
(revascularization, debridement of necrotic tissue
and advanced wound management including NPWT)
are unlikely to be efficacious in this subset of
wounds. There are no reports in the literature
describing the use of NPWT on the resulting ampu-
tation stump to aid healing.
In salvageable limbs, the extent of the necrosis
may not yet be severe enough to have directly
resulted in skin breakdown and so a wound may not
yet be present. Regardless of whether a wound is
present, the first line therapy in these patients is
thrombolysis, embolectomy, thrombectomy and
revascularization. Any wound management needs
can be assessed following successful revasculariza-
tion. However given the need for anti-thrombotic
drugs, application of NPWT may be inappropriate:
patients at high risk for bleeding (including those
taking anticoagulants or platelet aggregation
Negative pressure wound therapy in chronic wounds S13

inhibitors) have been identified by regulatory bodies
as high risk for NPWT related bleeding complications
[61]. There is no published evidence reporting the
use of NPWT on acute limb ischaemic wounds.
Use of NPWT in venous leg ulcers
Venous leg ulcers (VLU) occur as a result of
increased pooling of venous blood in the lower limb,
eventually causing skin breakdown. This may occur
when the valves in the legs that aid venous return
lose their functionality with increasing age and is
exacerbated by hypertension, immobility and
obesity. Patients who present with venous leg ulcers
typically have adequate arterial blood supply to the
lower limb. First line treatment following diagnosis
is compression therapy [76]. NPWT can be used as an
adjunct to compression [77,78].
The best clinical outcomes are achieved through
a multi-modal care pathway, which includes
nutrition, debridement, and compression therapy
along with advanced wound management.
Recommendation: If first line therapy
(compression) is not efficacious, NPWT should be
considered to prepare the wound for surgical
closure as part of a clinical pathway. Grade B;
Agreement in consultative phase 93%; Table 7.
The importance of wound bed preparation to
facilitate wound closure is well recognized and the
ability of NPWT to provide this function rapidly in
venous leg ulcer wounds has been reported (L1
[68]; L3: [25,79,80]) including those that did not
respond to compression therapy [68,79]. In a 60
patient RCT, Vuerstaek et al. [68] demonstrated
that NPWT was able to prepare chronic leg ulcers
for closure (57% of whom had VLU or mixed
venous/arterial ulcers) by STSG significantly
quicker than conventional therapy (saline gauze).
In this study, generation of granulation tissue over
100% of the surface of the wound took a median
time of 7 days in the NPWT group compared with
17 days in the conventional therapy group. These
patients had received up to 6 months of conser-
vative treatment including compression bandaging
prior to enrolment and had not achieved a signifi-
cant resolution of the wound during this period
suggesting that for patients where first line
therapy has failed, NPWT may be a useful tool in
progressing a wound to surgical closure. Lore e
et al. [80] applied NPWT to improve the quality of
the wound bed in VLU and reported a 40% reduc-
tion in fibrotic tissue on the surface of the wound
over a 6 day treatment with NPWT.
Venous leg ulcers may present as circumferen-
tial wounds. Some experimental studies have
indicated that the application of NPWT may result
in a reduction of tissue perfusion [81], which is of
obvious concern where wound healing is con-
cerned. Presence of a circumferential wound is
identified as a risk factor by regulatory bodies
because of the risk of decreased distal circulation
[61]. There are no reports in the published litera-
ture where application of circumferential VLU has
resulted in a complication however it is recom-
mended that NPWT be placed on a circumferential
wound with extreme caution and with frequent
monitoring of distal blood flow.
Following wound bed preparation, closure of
VLU is commonly carried out by skin grafting. The
advantages of applying NPWT to bolster STSG is
well supported in other wound types [82,83] (L1);
[84,85] (L2), and this has also been specifically
demonstrated in VLU: Ko rber et al. [86] reported
a retrospective comparative study which investi-
gated the ability of NPWT to enhance STSG take
rate onto prepared VLUs compared with post-
grafting treatment of gauze alone. A significant
increase in take rate was observed following the
use of NPWT, with 92% take rate compared to 67%
in the control group. Vuerstaek et al. [68] also
demonstrated a significant improvement in graft
take in chronic lower limb ulcers treated with
NPWT compared with conventional gauze dressings
(83% vs 70% respectively). Stetter et al. [87] (L3)
reported a successful single VLU case healed by
means of an STSG bolstered by NPWT.

Table 7 Evidence-based recommendations for the use of NPWT in venous leg ulcers.
Treatment goal Recommendation and Grade (AeD) Supporting reference and
evidence level (1e4)
Primary goal: If first line therapy (compression) is not efficacious, B L1: [68]a
To achieve wound closure NPWT should be considered to prepare the wound for
surgical closure as part of a clinical pathway.
Treatment variables Use of gauze may be considered to reduce pain C L1: [88]b
during dressing changes in susceptible patients. L3: [25]
a
Data extrapolated from this study as study population was composed of a mixture of lower limb ulcer aetiologies.
b
Data extrapolated from this study supports the recommendation indirectly.
S14
Patients with certain co-morbidities may also
have an increased risk of graft loss. This
increased risk may be reduced with the use of
NPWT. Ko rber et al. [86] also identified a negative
correlation of graft success in patients suffering
from diabetes mellitus or dermatoliposclerosis
albeit with small patient numbers. Where grafts
were bolstered using standard gauze dressings
the take rates were 50 and 62% respectively,
while the take rate was 100% in the group where
NPWT was used. This suggests that NPWT may be
of additional benefit in enhancing the take of
STSG in VLU patients suffering from these other
co-morbidities.
Recommendation: Use of gauze may be
considered to reduce pain during dressing changes
in susceptible patients. Grade C; Agreement in
consultative phase 87%; Table 7.
VLUs are known to be often very painful for
patients. One disadvantage of foam-based NPWT is
its tendency to allow newly formed granulation
tissue to grow into the interstices of the foam.
When the foam dressing is removed, this causes
disruption of the granulation tissue and is often
associated with pain and bleeding. Lore e et al.
[80] reported that 5 (36%) of their patients
required more analgesia during treatment with
NPWT. Three pain events were reported in Vuer-
staek et al. [68] (L1) compared with one in the
conventionally treated group. These studies used
foam-based NPWT. Conversely, Witkowski et al.
[25] reported that pain was either absent or
tolerable in all patients treated with gauze-based
NPWT. In a randomised study comparing gauze-
based and foam-based NPWT, Dorafshar et al.
reported that gauze-based NPWT provides a less
painful option compared with foam-based NPWT
[88]. This may be due to the lack of tissue in-
growth observed with gauze. Gauze may be
chosen in patients more susceptible to pain and
may be a means of reducing pain experienced
during dressing removal.
Conclusion
There is wide anecdotal acceptance of NPWT as
a successful therapy in a large range of different
wound indications. Despite an enormous number
of level 3 studies describing the safety and effi-
cacy of the technology there is a relative paucity
of comparative studies including randomized
clinical trials. The resulting evidence base is
therefore weaker than wide-spread adoption of
S. Vig et al.
NPWT would suggest. In light of this, consensus
becomes an important part of recommendation
generation. This is the third of three articles
reviewing the NPWT evidence base using
a process of expert panel recommendations. The
first publication reviewed the evidence base and
provided recommendations specifically for
trauma and reconstructive surgery [1], whilst the
second publication proposed recommendations
around treatment variables for NPWT use as
a result of the strength of published evidence
[89]. The recommendations proposed here have
been restricted by the extent of the evidence
base. The strongest recommendations to use
NPWT in chronic wound treatment algorithms can
be given regarding the treatment of diabetic foot
ulcers and weakest in the treatment of VLU. Most
of the recommendations centre around the
primary treatment goal for NPWT in chronic
wounds, which is to achieve wound closure
(either by secondary intention or preparing the
wound for surgical closure). Further level 1 and 2
comparative studies are required, in particular
describing the treatment of vascular leg ulcers,
chronic ischaemic lower limb wounds and pres-
sure ulcers, in order to enhance the strength of
the recommendations.
Competing interests
Authors Jenny Smith and Robin Martin are
employees of Smith & Nephew. The International
Expert Panel on Negative Pressure Wound Therapy
(EP-NPWT) is funded by Smith & Nephew. Where
no further conflicts of interest are stated, none is
known to exist. In addition to this funding, the
following financial relationships exist:
Norbert Runkel undertakes consultancy work for
Smith & Nephew in educational and speaking
engagements.
Charles K. Lee undertakes consultancy work for
Smith & Nephew in educational and speaking
engagements.
Hanne Birke-Sorensen has been member of two
expert panels involving the use of NPWT but
does not own shares or get any benefit from any
company supplying NPWT.
Raymond Dunn undertakes consultancy for and
has received funding for clinical trials from
Smith & Nephew.
Steven Jeffery undertakes consultancy work for
Smith & Nephew in educational and speaking
engagements.
Negative pressure wound therapy in chronic wounds
Mark E. Chariker undertakes consultancy work
for Smith & Nephew in the area of NPWT and has
served as a fact witness in legal testimony.
Caroline Dowsett undertakes consultancy work
for Smith & Nephew.
Fernando Ferreira has received honoraria from
Smith and Nephew and KCI Europe to train
healthcare professionals in the use of NPWT.
Stella Vig has received honoraria from Smith &
Nephew and KCI Europe in educational and
speaking engagements.
Role of funding source
S&N provided funding for travel and accommoda-
tion for all face-to-face expert panel meetings,
provided support regarding the published litera-
ture in NPWT, arranged and provided funding for
the consultative phase of the project (a sympo-
sium to 422 Healthcare professionals in Hamburg
Feb 2010), provided support during the drafting of
recommendations (authors Jenny Smith and Robin
Martin) and provided medical writing services in
preparation of this manuscript (author Jenny
Smith). The recommendations reflect the inde-
pendent and unbiased views of the panel and the
consensus derived during the project and the
content of the manuscript has not been unfairly
influenced by Smith & Nephew.
Disclaimer
These materials are provided for educational use
only and do not imply that the authors have
endorsed Smith & Nephews products in any way or
that the techniques being used are either endorsed
or recommended by Smith & Nephew.
Acknowledgements
The authors thank Elizabeth Huddleston (Smith &
Nephew) for help with the manuscript.
Appendix. Supplementary material
Supplementary data associated with this article
can be found, in the online version, at doi:10.
1016/j.jtv.2011.07.002.
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