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Guidelines for Preoperative

Patient Skin Antisepsis


Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Developed and originally presented by

Amber Wood, MSN, RN, CNOR, CIC, CPN


Amber Wood is a Perioperative Nursing Specialist at AORN where she has
served as lead author for the AORN Guideline for Environmental Cleaning and
the AORN Guideline for Preoperative Patient Skin Antisepsis. Amber offers
clinical information to members via the AORN Consult Line and contributes
regularly to the Clinical Issues column in the AORN Journal. She serves as the
staff liaison to the CDC Healthcare Infection Control Practices Advisory
Committee (HICPAC) and is a member of the Association for Professionals in
Infection Control and Epidemiology (APIC). Amber’s clinical experience
includes infection prevention, pediatric perioperative nursing, and clinical
research. Amber is a doctoral student in public health nursing at University of
Colorado, Denver, and she is certified as a CNOR, infection prevention and
control professional (CIC), and pediatric nurse (CPN).

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Objectives

• Discuss recent revisions in AORN’s guideline for preoperative


patient skin antisepsis.
• Describe the evidence supporting the guideline for
preoperative patient skin antisepsis.

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Sections

• Introduction
• Preoperative Bathing & Hair Removal
• Selection
• Application & Handling

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
INTRODUCTION

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Purpose

• Reduce the risk of the patient developing a surgical site


infection (SSI)

• Effective skin antiseptics rapidly and persistently remove


transient microorganisms and reduce resident microorganisms
to subpathogenic levels with minimal skin and tissue irritation.

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Scope

• Guidance for preoperative patient skin preparation


• Recommendations
– I: Bathing
– II: Hair removal
– III: Selection of antiseptics
– IV: Application of antiseptics
– V: Safe handling, storage, and disposal of antiseptics

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
PREOPERATIVE BATHING &
HAIR REMOVAL

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I. Preoperative Bathing

I.a. The patient should be instructed to bathe or shower before


surgery with either soap or a skin antiseptic on at least the night
before or the day of surgery. [1: Strong Evidence]

I.b. …develop a mechanism for evaluating and selecting products


for preoperative patient bathing. [2: Moderate Evidence]

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Evidence Review

• Collective Evidence
– Patient bathing may reduce the microbial flora
• Limitations/Gaps
– Optimal bathing procedures
– Antiseptics vs. soaps (ie, plain, antimicrobial)
– Whole body or only the surgical site
– Optimal timing before surgery
– Optimal number of baths or showers
• Benefits outweigh harms

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CHG-impregnated Cloths

• Growing body of evidence


• Unresolved issue
• Need more generalizable, high-quality research
– Healthy volunteers
– Orthopedic patients

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
II. Hair Removal

II.a. Hair at the surgical site should be left in place. [1: Strong
Evidence]

II.b. When necessary, hair at the surgical site should be removed


by clipping or depilatory methods in a manner that minimizes
injury to the skin. [1: Strong Evidence]

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Evidence Review

• Collective Evidence
– Hair at the surgical site should be left in place.
– When necessary, clipping may be associated with a lower SSI risk than
shaving with a razor.
• Limitations/Gaps
– Old studies
– Inadequate sample sizes, no standard SSI definition
– No studies comparing clipping and depilatory
• Benefits outweigh harms of leaving hair in place, if hair is
managed (interfere with procedure, fire hazard)

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Clipping Hair Outside the OR

• When feasible
• If not (eg, emergency, patient
anxiety), clip in a manner that
prevents dispersal of hair in the
OR
– Wet clipping
– Suction
[4: Benefits Balanced with Harms]

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Patient Self-Removal

II.a.1. The patient should be instructed to leave hair in place at


the surgical site before surgery. [2: Moderate Evidence]

• “Do not remove the hair down there.”


– Patient education campaign
– Improved patient compliance from 41% to 27% in a 3-year period
– Multiple interventions implemented
• Additional research is needed

Ng W, Alexander D, Kerr B, Ho MF, Amato M, Katz K. A hairy tale successful


patient education strategies to reduce prehospital hair removal by patients
undergoing elective caesarean section. J Hosp Infect. 2013;83(1):64-67. [IIIB]

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Shaving Hair of Male Genitalia

• Randomized controlled trial conflicts with recommendations to


clip rather than shave hair with a razor
– Clippers (n = 107) vs razors (n = 108)
– Outcomes: quality of hair removal, skin trauma, and SSI events
– Razors: less skin trauma, better hair removal, no increase in infections
– Wet or dry methods?
– Underpowered for SSI
• Additional research is needed

Grober ED, Domes T, Fanipour M, Copp JE. Preoperative hair removal on the
male genitalia: clippers vs. razors. J Sex Med. 2013;10(2):589-594. [IB]

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Challenges & Advice

• Patients are not bathing preoperatively


– Evaluate instruction and mechanism for assessing compliance
– Surgeon’s office and inpatient units/ICUs
– Wash patient’s surgical site in preoperative holding area, if feasible
• Patients are shaving before surgery
– Develop a patient education campaign
• Surgeons prefer a shave with a razor
– Mutual respect, collaboration, and involvement in decision making
– Peer to peer discussions, organization culture

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
References
Bathing Hair Removal
• Webster J, Osborne S. Preoperative bathing or • Tanner J, Norrie P, Melen K. Preoperative hair removal
showering with skin antiseptics to prevent surgical site to reduce surgical site infection. Cochrane Database
infection. Cochrane Database Syst Rev. Syst Rev. 2011;11:CD004122. [IA]
2012;9:CD004985. [IA] • Broekman ML, van Beijnum J, Peul WC, Regli L.
• Jakobsson J, Perlkvist A, Wann-Hansson C. Searching Neurosurgery and shaving: what's the evidence? J
for evidence regarding using preoperative disinfection Neurosurg. 2011;115(4): 670-678. [IIIA]
showers to prevent surgical site infections: a systematic • Sebastian S. Does preoperative scalp shaving result in
review. Worldviews Evid Based Nurs. 2011;8(3):143- fewer postoperative wound infections when compared
152. [IIA] with no scalp shaving? A systematic review. J Neurosci
• Kamel C, McGahan L, Polisena J, Mierzwinski-Urban Nurs. 2012;44(3):149-156. [IIIA]
M, Embil JM. Preoperative skin antiseptic preparations
for preventing surgical site infections: a systematic Both
review. Infect Control Hosp Epidemiol. 2012;33(6):608-
617. [IIA] • National Institute for Health and Care Excellence
(NICE). Surgical site infection: prevention and
• Chlebicki MP, Safdar N, O'Horo JC, Maki DG. treatment of surgical site infection.
Preoperative chlorhexidine shower or bath for https://www.nice.org.uk/guidance/cg74. Accessed
prevention of surgical site infection: a meta-analysis. Am February 11, 2015. [IVA]
J Infect Control. 2013;41(2):167-173. [IIA]

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SELECTION

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III. Selection

A multidisciplinary team,
including perioperative RNs,
physicians, and infection
preventionists, should select
safe and effective antiseptic
products for preoperative
patient skin antisepsis.

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Evidence Review

• Collective Evidence
– No one antiseptic is more effective than another for preventing SSI
– Selection of a safe and effective preoperative skin antiseptic should be
based on individual patient need
• Limitations/Gaps
– Most effective antiseptic
– Inadequate sample sizes
– Quality

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Health Care Organization

III.a. The multidisciplinary team should develop a mechanism for


product evaluation and selection of preoperative skin antiseptics.
[2: Moderate Evidence]

• Review current research literature


• FDA requirements
– Category I in the Tentative Final Monograph (TFM) for Over-the-Counter
(OTC) Healthcare Antiseptic Drug Products
– "New Drug Approval" (NDA)
• Single-use containers
• Colored or tinted

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FDA Approval Categories
Table 1. US Food and Drug Administration Categories of Patient Preoperative Skin
Preparations1
Active ingredient Category
Benzalkonium chloride IIIE
Chlorhexidine gluconate "New drug"
Chloroxylenol IIIE
Hexachlorophene II
Iodine tincture USP I
Iodine topical solution USP I
Povidone-iodine 5% to 10% I
Triclosan IIIE
Iodine Povacrylex/Isopropyl Alcohol2 New Drug2
E= Effectiveness
Reference
1. US Food and Drug Administration. Tentative Final Monograph for Healthcare Antiseptic Drug Products proposed rule. Fed Regist.
1994;59(116):31402-31452.
2. US Food and Drug Administration. New Drug Application (NDA) #21-586.

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Alcohol

• Isopropyl alcohol 70% is • “Painting” with alcohol is a


NOT approved for fire risk (flammable and
preoperative patient skin clear)
antisepsis • Alcohol is not sterile; there
– Approved only for skin have been outbreaks
antisepsis before injections (eg, involving Bacillus cereus
IV start)

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Patient Care Team

III.b. …select a safe, effective, health care organization-approved


preoperative antiseptic for the individual patient. [2: Moderate
Evidence]

Based on:
• Patient assessment
• Procedure type
• Review of the manufacturer’s instructions for use and
contraindications

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Procedure Type

III.b.3 The preoperative antiseptic product should be selected


based on the procedure type. [4: Benefits Balanced with Harms]

• Eye
• Gynecologic
• Orthopedic

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Allergies

III.b.1 …assess the patient for allergies and sensitivities to


preoperative skin antiseptics. [2: Moderate Evidence]

• Iodine, chlorhexidine, and alcohol


– Shellfish allergy is not related to iodine allergy
• Consider type of exposure (route) and frequency (single vs
repeat application)

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Contraindications

III.b.8. …collaboratively evaluate the risks and benefits of using


Class II or Class III FDA-approved antiseptics or other
alternative solutions (eg, soaps, saline). [4: Benefits Balanced
with Harms]

• Allergy
• Anatomical location
• Wounds

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Class II or IIIE
Table 1. US Food and Drug Administration Categories of Patient Preoperative Skin
Preparations1
Active ingredient Category
Benzalkonium chloride IIIE
Chlorhexidine gluconate "New drug"
Chloroxylenol IIIE
Hexachlorophene II
Iodine tincture USP I
Iodine topical solution USP I
Povidone-iodine 5% to 10% I
Triclosan IIIE
Iodine Povacrylex/Isopropyl Alcohol2 New Drug2
E= Effectiveness
Reference
1. US Food and Drug Administration. Tentative Final Monograph for Healthcare Antiseptic Drug Products proposed rule. Fed Regist.
1994;59(116):31402-31452.
2. US Food and Drug Administration. New Drug Application (NDA) #21-586.

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Iodism

III.b.5. …consult the physician when selecting iodine antiseptics


for patients susceptible to iodism. [2: Moderate Evidence]

• Patients with burns, patients with thyroid disorders, neonates,


pregnant women, lactating mothers
• Consider type of exposure (route) and frequency (single vs
repeat application)
• May rinse with sterile solution (eg, saline) after achieving
contact times required by the manufacturer

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Hairy Patients

III.b.4. …When using an alcohol-based skin antiseptic for


procedures involving an ignition source, hair at the surgical site
should be clipped before application of the antiseptic. [4: Benefits
Balanced with Harms]

• Leave the hair and choose an aqueous, water-based antiseptic


OR
• Clip the hair and choose an alcohol-based antiseptic

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Challenges & Advice

• Organization will need to approve MANY products


– Indicate preferred antiseptic, may be procedure/anatomical location
specific
• No FDA-approved alternatives when contraindicated (allergy,
wounds)
– Make an organizational decision as evidence and products become
available
• Surgeon preference
– Mutual respect, collaboration, and involvement in decision making
– Peer to peer discussions, organization culture

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
References
• US National Library of Medicine. DailyMed. Vaginal Prep
http://dailymed.nlm.nih.gov/. • American College of Obstetricians and Gynecologists
• US Food and Drug Administration. Tentative Final Women's Health Care Physicians, Committee on
Monograph for Healthcare Antiseptic Drug Products Gynecologic Practice. Committee Opinion No. 571:
proposed rule. Fed Regist. 1994;59(116):31402- Solutions for surgical preparation of the vagina.
31452. Obstet Gynecol. 2013;122(3):718-720. [IVB]
• Dumville JC, McFarlane E, Edwards P, Lipp A, • Amstey MS, Jones AP. Preparation of the vagina for
Holmes A. Preoperative skin antiseptics for preventing surgery. A comparison of povidone-iodine and saline
surgical wound infections after clean surgery. solution. JAMA. 1981;245(8): 839-841. [IIIB]
Cochrane Database Syst Rev. 2013;3:CD003949. [IA] • Lewis LA, Lathi RB, Crochet P, Nezhat C.
• Maiwald M, Chan ES-Y. The forgotten role of alcohol: Preoperative vaginal preparation with baby shampoo
a systematic review and meta-analysis of the clinical compared with povidone-iodine before gynecologic
efficacy and perceived role of chlorhexidine in skin procedures. J Minim Invasive Gynecol.
antisepsis. PLoS ONE. 2012;7(9). [IIA] 2007;14(6):736-739. [IIA]
• Haas DM, Morgan S, Contreras K. Vaginal
Shellfish preparation with antiseptic solution before cesarean
• American Academy of Allergy Asthma and section for preventing postoperative infections.
Immunology. AAAAI Position Statement: The Risk of Cochrane Database Syst Rev. 2013;1:CD007892. [IB]
Severe Allergic Reactions from the Use of Potassium • Hadiati DR, Hakimi M, Nurdiati DS. Skin preparation
Iodide for Radiation Emergencies. [IVB] for preventing infection following caesarean section.
Cochrane Database Syst Rev. 2012;9:CD007462. [IA]

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APPLICATION & HANDLING

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IV. Application

Perioperative team members should apply the preoperative


patient skin antiseptic in a safe and effective manner.

IV.d. Skin antiseptics should be applied using aseptic technique


and according to the manufacturer’s instructions for use. [4:
Benefits Balanced with Harm]

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Nonscrubbed Person

IV.c. A nonscrubbed perioperative team member should apply the


skin antiseptic using sterile technique. [4: Benefits Balanced with
Harm]

• Sterile gloves should be worn


• Nonsterile gloves may be worn
– If the applicator is of sufficient length to prevent contact of the gloved
hand with the antiseptic solution and the patient’s skin.
• Wear surgical attire that covers the arms

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Pre-filled Applicators

IV.d.4. …follow the manufacturer's instructions for use (eg,


maximum and minimum surface area per applicator) to apply the
skin antiseptic with uniform distribution. [4: Benefits Balanced
with Harms]

Sample:

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Scrub & Paint vs. Paint only

IV.d.6. …either scrub (ie, 7.5% povidone-iodine) and paint (ie,


10% povidone-iodine) or paint only may be used. [2: Moderate
Evidence]

• Conflicting evidence
• Need more research
• Regardless, the surgical site should be clean from soil and
debris before antisepsis (IV.b.)

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Fingers & Toes

IV.d.7. …care should be taken to apply the antiseptic to all


surfaces between fingers or toes. [2: Moderate Evidence]

• Bag technique
• Need more research

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Prepping the Mouth

IV.d.8. …care should be taken to prevent patient aspiration of the


antiseptic solution. [2: Moderate Evidence]

• Case report of pneumonitis after aspiration


– Throat pack used
– Advise NOT to irrigate the oral cavity

Chepla KJ, Gosain AK. Interstitial pneumonitis after betadine aspiration. J Craniofac
Surg. 2012;23(6):1787-1789. [VA]

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Dry Times

IV.e. …dry for the full time recommended in the manufacturer's


instructions for use before sterile drapes are applied. [2:
Moderate Evidence]

• Safety & Efficacy

IV.g.3. …communicate use of flammable skin antiseptics as part


of the fire risk assessment involving the entire perioperative team
before beginning a surgical procedure. [1: Strong Evidence]

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Prepping in Lithotomy

IV.f.3. A fluid-resistant pad should be placed under the patient's


buttocks... [2: Moderate Evidence]

• Added “fluid-resistant pad”


– Absorbent pad with fluid-resistant side
• Remove pad after antiseptic is dry and before sterile drapes are
applied
– If removed when wet, solution will continue to drip

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Ergonomics

IV.h. When lifting and holding the patient's extremity or head …


minimize muscle fatigue. [2: Moderate Evidence]

• Use two hands for holding


• Obtain assistance
• Use an assistive device
(Combination of these methods)

AORN guidance statement: Safe patient handling and movement in the perioperative
setting. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015:733-
752.

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V. Handling, Storage, Disposal

• Land of regulatory
requirements
– Single-use containers
– Dilution

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Single-use Containers

V.a. Skin antiseptics must be stored in the original, single-use


container. [1: Regulatory Requirement]

• FDA drug safety communication, Nov 2013


• Single-use packaging
• One time, one patient

Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.
Diluting Antiseptics

V.b. Skin antiseptics must not be diluted after opening. [1:


Regulatory Requirement]

• FDA drug safety communication, Nov 2013


• Do not dilute antiseptic products after opening
• Reduce product contamination

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Challenges & Advice

• Wearing jackets while prepping


– Shedding skin & hair  Cover arms
– Protect the prep from contamination
• Button jacket
• Wear appropriate size
• Tape up the sleeve
• Long sleeve scrub tops
• Single-use jacket or gown (it doesn't have to be sterile)*

*Scrubbed team members should not prep

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References
• Over-the-Counter Topical Antiseptic Bag Technique
Products: Drug Safety Communication - • Naderi N, Maw K, Thomas M, Boyce
FDA Requests Label Changes and DE, Shokrollahi K. A quick and effective
Single-Use Packaging to Decrease Risk method of limb preparation with health,
of Infection. US Food and Drug safety and efficiency benefits. Ann R Coll
Administration. Surg Engl. 2012;94(2):83-86. [IIB]
http://www.fda.gov/Safety/MedWatch/Sa • Incoll IW, Saravanja D, Thorvaldson KT,
fetyInformation/SafetyAlertsforHumanM Small T. Comparison of the effectiveness
edicalProducts/ucm374892.htm. of painting onto the hand and immersing
Accessed February 11, 2015. the hand in a bag, in pre-operative skin
• Guideline for a safe environment of care, preparation of the hand. J Hand Surg Eur
part 1. In: Guidelines for Perioperative Vol. 2009;34(3):371-373. [IIB]
Practice. Denver, CO: AORN, Inc; 2015: • Chou J, Choudhary A, Dhillon RS.
239-263. [IVA] Comparing sterile bag rubbing and paint
• Gottardi W. The influence of the on technique in skin preparation of the
chemical behaviour of iodine on the hands. ANZ J Surg. 2011;81(9):629-632.
germicidal action of disinfectant [IIC]
solutions containing iodine. J Hosp
Infect. 1985;6(Suppl A):1-11. [VA]

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Questions
and Answers
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