Guidelines for Preoperative Patient Skin Antisepsis

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.

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

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 Limitations/Gaps
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 Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.

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.

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

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

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

III. Selection A multidisciplinary team, including perioperative RNs, physicians, and infection preventionists, should select safe and effective antiseptic products for preoperative patient skin antisepsis. Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.

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

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 Hexachlorophene II Iodine tincture USP I Iodine topical solution USP Povidone-iodine 5% to 10% Triclosan 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): 2. US Food and Drug Administration. New Drug Application (NDA) # Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.

Alcohol Isopropyl alcohol 70% is NOT approved for preoperative patient skin antisepsis Approved only for skin antisepsis before injections (eg, IV start) “Painting” with alcohol is a fire risk (flammable and clear) Alcohol is not sterile; there have been outbreaks involving Bacillus cereus Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.

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

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

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

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 Hexachlorophene II Iodine tincture USP I Iodine topical solution USP Povidone-iodine 5% to 10% Triclosan 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): 2. US Food and Drug Administration. New Drug Application (NDA) # PCMX 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 Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.

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

Application & Handling

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

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

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

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

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

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): [VA] In one case report, a patient developed povidone-iodine aspiration pneumonitis after treatment of the oral and nasal cavity with irrigation of a diluted povidone-iodine solution, even though a throat pack was in place. In order to prevent aspiration, the authors of this report advised against irrigating the oral cavity with povidone-iodine. Copyright © 2015 AORN, Inc. All rights reserved. Used or adapted with permission.

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

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

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

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

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

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

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