Chinese Medical Journal 2011;124(5):719-724 719

Original article

Cosmetic outcome and surgical site infection rates of antibacterial
absorbable (Polyglactin 910) suture compared to Chinese silk
suture in breast cancer surgery: a randomized pilot research

ZHANG Zhong-tao, ZHANG Hong-wei, FANG Xue-dong, WANG Li-ming, LI Xiao-xi, LI Ya-fen,
SUN Xiao-wei, Judith Carver, Dorella Simpkins, Jessica Shen and Martin Weisberg

Keywords: antibacterial; absorbable suture; silk suture; cosmesis; surgical site infection

Background The primary objective of this multicenter post-market study was to compare the cosmetic outcome of
triclosan-coated VICRYL* Plus sutures with Chinese silk sutures for skin closure of modified radical mastectomy. A
secondary objective was to assess the incidence of surgical site infection (SSI).
Methods Patients undergoing modified radical mastectomy were randomly assigned to coated VICRYL* Plus
antibacterial (Polyglactin 910) suture or Chinese silk suture. Cosmetic outcomes were evaluated postoperatively at days
12 (2) and 30 (5), and the evidence of SSI was assessed at days 3, 5, 7, 12 (2), 30 (5), and 90 (7). Cosmetic
outcomes were independently assessed via visual analogue scale (VAS) score evaluations of blinded incision
photographs (primary endpoint) and surgeon-assessed modified Hollander Scale (mHCS) scores (secondary endpoint).
SSI assessments used both CDC criteria and ASEPSIS scores.
Results Six Chinese hospitals randomized 101 women undergoing modified radical mastectomy to closure with coated
VICRYL* Plus suture (n=51) or Chinese silk suture (n=50). Mean VAS cosmetic outcome scores for antibacterial suture
(67.2) were better than for Chinese silk (45.4) at day 30 (P <0.0001)). Mean mHCS cosmetic outcome total scores, were
also higher for antibacterial suture (5.7) than for Chinese silk (5.0) at day 30 (P=0.002).
Conclusions Patients using coated VICRYL* Plus suture had significantly better cosmetic outcomes than those with
Chinese silk sutures. Patients using coated VICRYL* Plus suture had a lower SSI incidence compared to the Chinese
silk sutures, although the difference did not reach statistical significance. (ClinicalTrials.gov NCT 00768222)
Chin Med J 2011;124(5):719-724

he manner in which an incision is closed and
managed postoperatively can influence cosmetic
outcome. Some surgeons in China continue to use
traditional silk sutures to close skin incisions because the
material handles well and functions well to achieve
wound edge apposition. Silk sutures are generally used in
a simple interrupted transcutaneous pattern, leaving a
loop of suture exteriorized through the skin. Silk sutures
must be removed postoperatively since silk is not
absorbable while the use of any transcutaneous suture
technique is associated with the potential to leave suture
track scars where the sutures passed through the skin.

A 21-day swine study of full thickness skin incisions
closed with MONOCRYL Plus (antibacterial) Suture
used in a subcuticular (intradermal) suture pattern
compared to incisions closed with Chinese Silk Suture in
a transcutaneous simple interrupted suture pattern showed
superior cosmetic outcome in the Plus antibacterial suture
group.
1
The Plus antibacterial suture treated with triclosan,
a non-antibiotic antimicrobial that kills bacteria and
inhibits bacterial colonization on the suture, and
addresses a potential risk factor associated with surgical
site infection (SSI). A 10-year close observation of 40 915
surgical wounds showed wound infection rates ranging
from 1.8% to 2.8% in each of the years observed.
2
Wound
infection remains a huge burden to health care systems
3

and to patients. However, no randomized controlled trial
has been conducted in this setting to assess antibacterial
properties of triclosan-coated sutures.
4-7
This pilot study
T
DOI: 10.3760/cma.j.issn.0366-6999.2011.05.016
Department of General Surgery, Beijing Friendship Hospital,
Capital Medical University, Beijing 100050, China (Zhang ZT)
Department of General Surgery, Zhongshan Hospital, Fudan
University, Shanghai 200032, China (Zhang HW)
Department of General Surgery, Second Hospital, Jilin University,
Changchun, Jilin 130041, China (Fang XD)
Department of General Surgery, Second Hospital, Dalian Medical
University, Dalian, Liaoning 116027, China (Wang LM)
Department of Vascular and Thyroid Surgery, The First Affiliated
Hospital of Sun Yat-Sen University, Guangzhou, Guangdong
510080, China (Li XX)
Department of Breast Surgery, Ruijin Hospital, Shanghai Jiaotong
University School of Medicine, Shanghai 200025, China (Li YF)
Strategic Medical Affairs, Johnson & Johnson Medical Shanghai,
Shanghai, China (Sun XW)
Evidence Based Medicine, Clinical Development (Carver J,
Simpkins D and Shen J), Medical Affairs (Weisberg M), Ethicon
Inc., Somerville, NJ, USA
Correspondence to: Dr. ZHANG Zhong-tao, Department of
General Surgery, Beijing Friendship Hospital, Capital Medical
University, Beijing 100050, China (Fax: 86-10-63138475. Email:
zhangzht@medmail.com.cn)
This research was supported by Ethicon Inc., a Johnson & Johnson
Company, New Jersey.
Chin Med J 2011;124(5):719-724 720
was designed to compare the cosmetic outcomes of
coated VICRYL* Plus antibacterial (Polyglactin 910)
(Active group) suture to Chinese silk (Control group)
Suture following modified radical mastectomy.

METHODS

Study design
This was a randomized, multicenter, open-label pilot
study designed to evaluate and compare the cosmetic
effects of two commercially available products used
during scheduled modified radical mastectomy. The
incidence of SSI was also monitored and analyzed. The
study was conducted by investigators from 6 Chinese first
tier hospitals from October 2008 to May 2009 according
to precepts established by the International Conference on
Harmonization, Guidelines for Good Clinical Practice,
and the Declaration of Helsinki, 5th Revision, 2000. The
protocol was approved by the institutional review boards
of all study centers. Each patient gave written informed
consent prior to participation.

Inclusion and exclusion criteria
Eligibility criteria included women age 18 years,
scheduled for clean modified radical mastectomy, signed
hospital approved informed consent and surgical wound
classified class I (CDC SSI Surgical Wound
Classification). Patients were excluded if they met any of
the following criteria: (1) patients undergoing surgery for
modified radical mastectomy with immediate breast
reconstruction, cosmetic breast operations, reduction,
expansion, insertion of a prosthesis, duct ectasia, or
infective breast disease or implant; (2) patients with
surgical wounds identified as Class II, III or IV using
CDC SSI Surgical Wound Classification; (3) patients
have inflammatory cancers, skin ulceration; (4) known
allergy or intolerance to triclosan; (5) patients with
anticipated compromised wound healing or chronic
immune deficiency (for example diabetes, prolonged
steroid use, AIDS or substance abuse); (6) serious heart
and/or lung disease; (7) skin scar history or family history;
(8) patients who received an experimental drug or used an
experimental medical device within 30 days prior to the
planned start of treatment; (9) employees of the
investigator or study center with direct involvement in the
proposed study or other studies under the direction of that
investigator or study center; (10) in the opinion of the
investigator, unlikely to comply with or complete the
90-day follow up visit.

Randomization and device regimens
Randomization was used to avoid bias and to enhance the
validity of statistical comparisons across treatment groups.
To ensure an equal distribution of treatments in each
center, a block randomization procedure on a site basis
was used with a block size of 4. After the patients had
given informed consent, they were randomly assigned to
either the active group (with intradermal closure) or
control group (with simple interrupted closure) according
to a sequentially numbered sealed envelope from an
ETHICON computer-generated randomization schedule.
The patients and surgeons remained blinded up to the
time of wound closure when a sealed randomization
envelope was opened by a member of the operating room
staff to determine the suture group to be used. To avoid
bias associated with regional procedural and closure
methods, all involved investigators were trained during an
investigator meeting to consolidate modified radical
mastectomy. Investigators performed the procedure and
closed the skin incision in accordance with unified
standard of care.

Effectiveness measurements
Eight study visits were conducted for cosmetic outcome:
screen, surgery (day 0), post-treatment day 3, day 5, day 7,
day12 (2), day 30(5) and day 90(7). The primary
effectiveness endpoint of this study was the score for the
cosmetic outcome, evaluated by the blinded Central
Assessor from the surgical site wound photograph(s) at
day 30 using a validated 100 mm visual analogue scale
(VAS).
8-10
All photographs were taken using a Canon G9
12-megapixel camera provided with predetermined
settings by surgeons who had been trained with camera
use instruction and photograph measure method during
investigator meeting. The bar coded smart media cards
identified the surgical site wound photograph per subject
and visit and were returned to cosmetic outcome
evaluation vender, Canfield Scientific. Inc. for processing.
After all subjects completed the day 30 visit, Canfield
Scientific. Inc. blinded the photographs and forwarded
them for Central Assessor for review and scoring. The
Central Assessor, a plastic surgeon experienced in
evaluating scars, performed the independent review on
the 2-dimensional breast scar photographs blinded with
respect to subject, visit, investigator and treatment
information. A vertical mark was made on an evaluation
form with a horizontal 100-mm VAS marked worst
possible scar (0) at one end and best possible scar (100)
at the other end. A score between 0 and 100 was derived
by measuring the distance between the vertical mark and
0. A proctor verified that the image being viewed
corresponded to the sequence number within the review
software. No discussion was allowed between the proctor
and Central Assessor during the review. Documentation
of the review and the completed forms were returned to
the photography vendor for processing and un-blinding.
Day 12 photographs were taken to ensure picture quality
and standardization.

The secondary effectiveness endpoints included (1) the
photograph score of cosmetic outcome at day 12; (2) the
modified Hollander Cosmetic Scale (mHCS) score at
days 12 and 30 assessed by non-blinded investigator. The
modified Hollander Scale assigns a score ranging from 0
(best) to 6 (worst) for six categories (Table 1); (3) SSIs
were identified using ASEPSIS wound scores and CDC
criteria. The ASEPSIS wound scoring (Table 2) method
allots points during the first postoperative week for wound
Chinese Medical Journal 2011;124(5):719-724 721
Table 1. Modified Hollander Scale (mHCS)
Categories Yes No
Step off borders: As you run your finger over the healed wound, is there a step of the edges? 1 0
Contour irregularities: is the skin near the wound wrinkled or puckered? 1 0
Wound margin separation: Is the gap between the wound edges at the widest point (i.e., scar width) >2 mm? 1 0
Edge inversion: Do either of the wound edges invert (sink or cut) into the wound? 1 0
Excessive inflammation: Is there evidence of swelling, redness or discharge from the wound? 1 0
Overall appearance Poor 1 Good 0

appearance characteristics and then for additional
treatment related to longer term clinical consequences of
infection. Point totals represent a category of infection:
010, satisfactory healing; 1120, disturbance of healing;
2130, minor wound infection; 3140, moderate infection;
>40, severe wound infection. Since daily dressing
changes were not post-operative standard of care
following modified radical mastectomy, ASEPSIS wound
surveillance was performed at days 3, 5, 7, 12, 30 and 90.
The CDC criteria method of assessing SSI defined
post-operative infections according to the specified
criteria as Superficial Incisional SSI, Deep Incisional SSI,
or Organ/Space SSI. CDC wound surveillance was
performed at days 3, 12, 30 and 90.

Table 2. The wound score: ASEPSIS
Additional treatment criterion Points
Antibiotics for wound infection 10
Drainage of pus under local anesthesia 5
Debridement of wound under general anesthesia 10
Serous discharge
*
Daily 05
Erythema
*
Daily 05
Purulent exudate
*
Daily 010
Separation of deep tissues
*
Daily 010
Isolation of bacteria from wound 10
Stay as inpatient prolonged over 14 days as result of wound infection 5
*
A score is given for each only on 3 of first 7 postoperative days.

Demographics, physical and pertinent medical history,
concomitant medications and risk factors that could
impede wound healing were recorded. Procedure
information, tumor staging, and culture for suspected
infection were recorded. All wound and device related
adverse events and unanticipated adverse device events
observed during the study were collected. All collected
data from each subject were entered on Case Report Form
(CRF). The CRFs were reviewed by sponsors delegates
for accuracy and completeness during on-site monitoring
visits and the data were entered into the clinical trial
database and verified for accuracy.

Statistical analysis
This was a pilot study and not statistically powered. No
formal sample sizing was performed for the study. Eighty
subjects (40 per group) were considered adequate to
achieve study objectives to compare two treatment groups
descriptively. To account for a 20% drop out rate,
approximately 1520 subjects were enrolled from each
site. Approximately 100 subjects were to be enrolled into
the study to yield 80 evaluable subjects. The primary
effectiveness endpoint was the score for the cosmetic
outcome, evaluated by the blinded Central Assessor from
the surgical site wound photograph(s) at Day 30 using a
validated 100 mm VAS. Two analysis sets were defined
for primary effectiveness variable analysis. The
intent-to-treat (ITT) analysis set (Full Analysis Set)
consisted of all randomized subjects. Therefore, protocol
violators were included in the ITT analysis set. The
Evaluable (Per-Protocol) analysis set (PP) consisted of all
ITT subjects who had data on the primary effectiveness
parameter at day (305) and who did not have major
protocol deviations (i.e., having an impact on the primary
endpoint). The primary effectiveness endpoint was
summarized descriptively by treatment group for the ITT
subjects with available data and for the PP set. The ITT
analysis was considered as primary effectiveness analysis,
because less than 5% of the randomized subjects
experienced major protocol deviations. Missing data for
the primary endpoint was not imputed (was ignored). The
two-sided t-test was used to compare the mean VAS score
between the two treatment groups, for both ITT and PP
analysis sets, with the ITT analysis being considered
primary. The database setup software was Oracle Clinical
Version 4.1 and the data quality control was performed
according to the departmental standard operating
procedures through the use of edit checks and data listing
review sessions. All statistical analyses and summaries
were performed using SAS

for Windows Version 9.1.3

on Enterprise Guide 4.1 (USA). A significance level of
0.05 was used for all statistical comparisons. The
categorical data were summarized by frequencies along
with the associated percentages. The continuous variables
were summarized by number of subjects, mean, standard
deviation, minimum, maximum, and median.

RESULTS

Patient characteristics
A total of 101 patients, Active (n=51) and Control (n=50),
were enrolled into the study between October 2008 and
February 2009. Ninety three women, 47 in Active and 46
in Control groups, completed the study. The enrollment,
study article allocation, patient follow up, and analysis of
this parallel randomized trial are shown in Figure 1.

Baseline characteristics, i.e., age, BMI, diabetes, COPD,
asthma, smoking history, working outside the home and
tumor stage of the patients were comparable between the
groups (Tables 3 and 4).

Cosmetic outcome
The analysis showed that the day 30 mean VAS score of
the Active group was higher (better cosmetic outcome)
than that of the control group for both the PP and ITT
Chin Med J 2011;124(5):719-724 722


Figure 1. Trial flow diagram.

Table 3. Baseline characteristics of patients
Variables
Category/
Statistic
Active group
(n=51)
Control group
(n=50)
Age (years) Median (range) 51.0 (32.0, 82.0) 52.0 (34.0, 75.0)
BMI (kg/m
2
) Median (range) 23.9 (16.0, 28.0) 23.6 (18.2, 34.0)
Diabetes (n (%)) No 51 (100.0) 50 (100.0)
COPD (n (%)) No 51 (100.0) 50 (100.0)
Asthma (n (%)) No 51 (100.0) 50 (100.0)
Current 0 1 (2.0)
Former 0 2 (4.0)
Smoking history
(n (%))
Never 51 (100.0) 47 (94.0)
Yes 5 (9.8) 8 (16.0) Working outside the
home (n (%)) No 46 (90.2) 42 (84.0)
Tumor staging Stage 0 0 1 (2.0)
(n (%)) Stage I 19 (37.3) 23 (46.0)
Stage IIA 17 (33.3) 16 (32.0)
Stage IIB 6 (11.8) 0
Stage IIIA 5 (9.8) 5 (10.0)
Stage IIIB 1 (2.0) 3 (6.0)
Stage IIIC 2 (3.9) 1 (2.0)
Stage IV 1 (2.0) 1 (2.0)

analyses. The difference was statistically significant for
both analyses (both P <0.0001). Similar results were
observed for the secondary cosmesis endpoints: Day 12
mean VAS score and mHCS mean total scores displayed
below (Table 5).

To put the statistical significance in perspective, the
mHCS, a much smaller scale than the 100 point VAS, is
calculated by adding the individual scores of 5 specific
potential imperfections (step off borders, contour
irregularities, wound margin separation, wound edge
inversion, excessive inflammation) and a sixth subjective
component, overall appearance. The maximum possible
score of 6 is considered by the creators of the scale to be
optimal, and less than 6 is suboptimal. At day 30, the
investigator assessment of the sixth component, overall
appearance, was rated as good for all subjects in the
Active group, while there were 11 subjects (24.4%) rated
poor in the control group. Of the Active subjects, 98%
had scores of 5 or better, and one (2%) had a score of 4.
Of the control subjects, 73% had scores of 5 or better,
13% scored 4 and 7% scored 3 and 2, respectively
(Figure 2).

SSI outcome
The total mean ASEPSIS scores of the Active group was
lower (fewer signs associated with infection) than that of
the Control group at all times measured (days 3, 5, 7, 12,
30 and 90), although the differences did not reach
statistical significance at day 12 and beyond. The wound
characteristics and additional endpoints measured were
comparable between the two groups at all specified time
points.

Similar results were observed using the CDC criteria. No
incidence of SSI was reported through day 12 in either
the active or control group. SSI was identified in 4.3%
(2/46) of the subjects treated with active suture, compared
to 11.1% (5/43) of those treated with the Control suture at
day 30. There were no further changes identified in the
incidence of SSI through day 90.

Safety data
The majority of the adverse events reported were typical
for the post-operative populations studied, mild in
intensity, considered not related to study device by the
investigators, and were similar in type and reported
incidence. Unexpected dressing changes were necessary
for patients who experienced adverse events, described as
accumulation of fluid, skin flap necrosis, gangrene, and
SSI. It is likely that some of these events may be
associated with surgical technique rather than the type of
suture utilized (Table 6).

DISCUSSION

The results of this study demonstrated that patients
undergoing modified radical mastectomy whose incisions
were closed with subcuticular antibacterial absorbable
(Active) suture exhibited a better cosmetic outcome than
those closed with silk (Control) suture used in a simple
interrupted suturing technique.

The cosmetic outcome was assessed using two instruments.
For the primary endpoint, an independent plastic surgeon
used a VAS to score blinded surgical site wound
photographs. The secondary endpoint, categorical mHCS,
was completed by each un-blinded operating surgeon to
report direct observation of cosmetic outcomes. While not
stratified to separate out the effect of the material or
technique used, the study showed both instruments
provided comparable results in terms of cosmetic
outcomes at Days 12 and 30. Although the superiority of
the cosmetic results in the Active group was statistically
significant, the study was not designed with stratification
Chinese Medical Journal 2011;124(5):719-724 723
Table 4. Enrollment by center and treatment group (n (%))
Hospitals Department Category/Statistic Active group (n=51) Control group (n=50) Total
Not withdrawn 12 (92.3) 11 (91.7) 23 (92.0) Beijing Friendship Hospital, Capital
Medical University
Department of General Surgery
Lost to follow-up 1 (7.7 ) 1 (8.3) 2 (8.0)
Zhongshan Hospital, Fudan University Department of General Surgery Not withdrawn 10 (100.0) 10 (100.0) 20 (100.0)
Not withdrawn 4 (80.0) 3 (75.0) 7 (77.8) Ruijin Hospital, Shanghai Jiaotong
University School of Medicine
Department of Breast Surgery
Withdrew consent 1 (20.0) 1 (25.0) 2 (22.2)
Not withdrawn 10 (100.0) 8 (80.0) 18 (90.0) Second Hospital, Jilin University Department of General Surgery
Withdrew consent 0 (0) 2 (20.0) 2 (10.0)
Not withdrawn 8 (88.9) 8 (100.0) 16 (94.1) Second Hospital, Dalian Medical
University
Department of General Surgery
Other 1 (11.1) 0 ( 0) 1 (5.9)
The First Affiliated Hospital of Sun Department of Vascular and Not withdrawn 3 (75.0) 6 (100.0) 9 (90.0)
Yat-Sen University Thyroid Surgery Other 1 (25.0) 0 (0) 1 (10.0)

Table 5. Effectiveness endpoints of cosmetic outcome score
Effectiveness endpoints
Active
group
Control
group
P
values

67.218.2

45.4 12.0

<0.0001
Day 30 VAS cosmetic outcome score
*

ITT

PP

67.6 18.2 45.5 11.7 <0.0001

Day 12 VAS score

ITT

67.312.3 46.6 6.5 <0.0001

Day 12 mHCS total score

ITT

5.70.8

5.2 1.2 P=0.03
Day 30 mHCS total score

ITT

5.70.5

5.0 1.2 P=0.002
Data are presented as mean valueSD.
*
Primary effectiveness endpoint;

Secondary effectiveness endpoint.

ITT, Intent-to-Treat; Numbers of ITT are 51
in Active group, 50 in control group.

PP, Per Protocol; Numbers of PP are 46 in

Active group, 43 in control group.



Figure 2. At Day 30, the investigator assessment of the sixth
component, overall appearance, was rated as good for all
subjects in the Active group, while there were 11 subjects
(24.4%) rated poor in the Control group. Of the Active subjects,
98% had scores of 5 or better, and one (2%) had a score of 4. Of
the Control subjects, 73% had scores of 5 or better, 13% scored
4 and 7% scored 3 and 2, respectively.

Table 6. Number of adverse events (AEs) reported during study
treatment
Variables
Active Group
(n=51)
Control Group
(n=50)
Total number of AEs 15 (NA) 21 (NA)
Total number of severe AEs 1 (NA) 3 (NA)
Subject with at least 1 AE (n (%)) 15 (29.4) 19 (38.0)
Serious (n (%)) 1 (2.0) 3 (6.0)
Severe (n (%)) 0 (0) 2 (4.0)
Death (n (%)) 0 (0) 0 (0)
Possibly related to device and procedure (n (%)) 2 (3.9) 3 (6.0)
Related or possibly related to procedure (n (%)) 6 (11.8) 6 (12.0)

to separate out the effect of the antibacterial properties of
the active suture or the suturing technique, a limitation of
the study.
The study was unique in that it used 2 different methods
to assess the incidence of SSI: The CDC definition of
surgical site infection, and the ASEPSIS Wound Score, a
predictor of infection that may develop once the patient
leaves the hospital. While the ASEPSIS method has been
used in research, it has not been routinely used in clinical
practice, although it is gaining use in European studies.
Neither method resulted in a statistically significant
difference in the incidence of SSI between the two groups,
but both methods reported a higher rate of infection in the
Control group.

Further parallel, randomized studies powered to detect a
difference in SSI are needed to validate this observation
and to demonstrate correlation between the two methods
of assessing SSI and to what degree the suture material,
antibacterial coating, and/or suturing technique
contributed to these results and to the superior cosmesis.

Acknowledgments: We gratefully acknowledge Dr. WEI Min,
plastic surgeon independent-assessor, sub-investigators Profs. QU
Xiang, ZHU Li, GAO Zhen-ming, Drs. GE Zhi-cheng, WANG
Hong, ZHANG Yan who operated on/followed patients, the
ETHICON Statistical Department for programming and analysis,
and Phyllis Britnell for medical writing and editing assistance.

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(Received November 29, 2010)
Edited by HAO Xiu-yuan