Review: Perspective on Ocular Toxicity of Presurgical Skin Preparations
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www.surgicalneurologyint.com Surgical Neurology International Editor-in-Chief: Nancy E. Epstein, MD, Clinical Professor of Neurological Surgery, School of Medicine, State U. of NY at Stony Brook. SNI: Spine Editor Nancy E. Epstein, MD Clinical Professor of Neurological Surgery, School of Medicine, State U. of NY at Stony Brook Open Access Review Article Review: Perspective on ocular toxicity of presurgical skin preparations utilizing Chlorhexidine Gluconate/Hibiclens/Chloraprep Nancy E Epstein MD, FACS Clinical Professor of Neurosurgery, Schoold of Medicine, State University of New York at Stony Brook, NY and ℅ Dr. Marc Agulnick,1122 Franklin Avenue Suite 106, Garden City, NY 11530. E-mail: *Nancy E Epstein - [email protected] ABSTRACT Background: Chlorhexidine Gluconate (CHG), Hibiclens (4% CHG with 4% Isopropyl Alcohol Detergent), and Chloraprep (i.e. labeled CHG-based solutions), utilized as preoperative surgical preparatory solutions may all cause severe oculotoxicity and ototoxicity. Alternatively, 10% Povidone-Iodine (PI) solutions without detergent demonstrate minimal toxic effects on the eyes and ears. *Corresponding author: Methods: Based on studies from 1984 to 2021, we compared the safety/efficacy of CHG-based versus PI-based Nancy E Epstein, MD, FACS, solutions utilized for presurgical skin preparation near the cornea/eyes and ears (i.e., predominantly for cranial or Clinical Professor of cervical spine surgery). Neurosurgery, School of Results: Some studies documented that even minimal exposure (i.e., “splash risk”) during face/neck skin Medicine, State University of preparation with CHG-based solutions could result in irreversible corneal injury and ototoxicity. Within minutes New Yorrk at Stony Brook, NY to hours, CHG-based non-detergent solutions posed the risks of; corneal epithelial edema, anterior stromal and ℅ Dr. Marc Agulnick, 1122 edema, conjunctival chemosis, bullous keratopathy, and de-epithelialization. Notably, even occlusive dressings Franklin Avenue Suite 106, like Tegaderm could not protect against CHG penetration. Alternatively, PI-based solutions posed no to minimal Garden City, NY 11530. ocular and/or ototoxicity, while often demonstrating comparable protection against surgical site infections (SSI). [email protected] Conclusion: Chlorhexidine Gluconate (CHG), Hibiclens, and Chloraprep (i.e. CHG-based solutions) are often used as skin preparations near the face/eyes/spine (i.e., particularly anterior/posterior cervical procedures). Received : 07 June 2021 However, if these solutions come in contact with the eyes, corneal irritation, abrasions, and even blindness may Accepted : 08 June 2021 result. Alternatively, PI non-detergent solutions demonstrate safety/minimal oculotoxicity/ototoxicity, while frequently showing comparable efficacy against SSI. Published : 06 July 2021 Keywords: Chloraprep, Corneal toxicity, Hibiclens, Oculotoxicity, Ototoxicity, Povidone-iodine solution, Skin DOI preparation 10.25259/SNI_566_2021 Quick Response Code: INTRODUCTION Chlorhexidine gluconate (CHG), Hibiclens (4% CHG and 4% Isopropyl Alcohol), and Chloraprep (i.e. CHG-based solutions) presurgical skin preparations have well-documented oculotoxicity and ototoxicity. erefore, great care must be utilized to avoid eye and ear contact when utilizing these presurgical preparation solutions when performing cranial and/ or anterior or posterior cervical spine surgery, and occasionally, other procedures near the eyes/ears. Alternatively, Povidone-Iodine (PI) non-detergent solutions have demonstrated is is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. ©2021 Published by Scientific Scholar on behalf of Surgical Neurology International Surgical Neurology International • 2021 • 12(335) | 1 Epstein: Review: Perspective on ocular toxicity of presurgical skin preparations utilizing Chlorhexidine Gluconate minimal eye/ear toxicity, while often showing comparable Lavacol (70% ethanol), 7.5% povidone iodine scrub (PIS plus prophylaxis against surgical site infection (SSI). Here detergent), and 10% PI solutions (PI without detergent). At 3 h, we reviewed the relative risks/benefits, and alternatives all skin preparations resulted in marked de-epithelialization, to CHG-based preoperative skin preparation solutions conjunctival chemosis, and/or anterior stromal edema except versus PI non-detergent solutions for patients undergoing the 10% PI solution without detergent and 0.9% Normal Saline. procedures near the eyes/ears (i.e. cranial surgery, spinal ey concluded that only the 10% PI solution without detergent surgery, and occasionally other procedures). and NS showed no significant toxicity, while all other skin preparations were ototoxic or oculotoxic (i.e., to the cornea). 1984 RABBIT STUDY DOCUMENTED CORNEAL TOXICITY OF CHG/HIBICLENS DOCUMENTATION OF CORNEAL TOXICITY FOR CHG-BASED SOLUTIONS In 1984, Mac Rae et al. evaluated the corneal toxicity in rabbits of multiple skin preparations [Table 1].[5] ese included; Multiple studies demonstrated significant corneal toxicity tincture of iodine (2% iodine, 2.35% sodium iodine, 46% when using CHG-based preoperative skin preparation ethanol), Hibiclens (4% chlorhexidine; 4% isopropyl alcohol solutions for cranial, cataract, or spinal surgery [Table 1].[6,9] with detergent), PhisoHex (3% hexachlorophene/detergent), Van Rij (1995) noted that mistakenly using CHG, Cetrimide Table 1: Oculotoxicity of CHG-based versus PI-based solutions when used as a skin preparation. Near the eyes/ears (i.e., face) and cervical spine. Author Ref# Study design Data Data Data Conclusion Year Journal Mac Rae et al.[5] Corneal Tox Preop Groups Study Groups Findings 1 Week; all 1984 SP NS Phisohex 5 Min AA Corneas Normal Am J Rabbits TincI (2% I, 2.35% Lavachol (70% Moderate CEE Not Conclude Ophthalmol Used NAI/46%) Ethanol Ethanol) Saline 10% PIS without BioM, Corneal Hibiclens 4% 7.5% PI Scrub/Det 3 Hrs Det Pachymetry CHG+4% Isopropyl 10% PIS No Det Marked DE, CC, Min Tox Healing Studies Alcohol Det ASE All Other Preps Tox EM Not 10% PIS and to Cornea 0.9% NS Van Rij et al.[9] Tox Keratopathy Due to Use of Irrigation 3 Years Chose Wrong Result Acute CEE, Light EM CEE, LK 1995 Accidental Use CHG, Solutions by OPH Bottle 5x BK Disrupted/ Doc Cetrimide and Cialit (Some Bottles CHG, Cetrimide 4 Pts Pen Loss ECL Ophthalmol Cataract Surgery Identical) CHG/Cetrimide and 1 Pt Cornea Covered Cialit Conjunctival Flap Murthy et al.[6] Prog UK Due to Case 45 yo F Rx for 8 wk Drops Pathology Hibiclens=CHG 2002 Topical UK with topical CHG Near Total Loss Ulceration 4% with +Det Cornea CHG (0.02%) 0.02% (+Propamidine Corneal Epithelium Loss of Bowman’s Culture 0.1%) Eye Drops Prog UK Membrane No Organisms Required Pen LK Apoptosis But Result Keratoplasty LEC Progressive UK Darouiche CHG (409) versus PI Hypothesis SSI Significantly Lower DATA CDC No REC et al.[3] (440) for Prep Surgical CHG Better an PI CHG versus PI 300-500,000 SSI/Yr/ Which to Use 2010 Site Prep to Avoid SSI <SSI Superficial and USA CHG versus PI NEJM In 30 Days Postop Deep CDC REC to Avoid SSI 2% CHG Inserted in 27 Million Catheters Operations/yr/ USA Bever et al.[1] CHG SP 2 Cases Highly Tox CHG Use Avoid If use CHGHCG 2016 High Risks Eye Tox Corneal Damage CHG to Eye Contact with Eyes Add Protect World -4% CHG SP Despite Recommend: 10% PIS AEP+ Neurosurg Tight OC Eye SP Near Eyes Tight OC Dressing (Contd...) Surgical Neurology International • 2021 • 12(335) | 2 Epstein: Review: Perspective on ocular toxicity of presurgical skin preparations utilizing Chlorhexidine Gluconate Table 1: (Continued). Author Ref# Study design Data Data Data Conclusion Year Journal Steinsapir and CHG for Ker Facial PS Toxic to Research CHG should NOT PIS Safe Effective Woodward[8] 11 Sentinel Cases Cornea PubMed be Used on Face and Choice 2017 Late1980’s Splash Risk Embase Scalp Dermatol Surg Irreversible Damage LexisNexis Risk ME Minimal Exposure Databases Brodie et al.[2] BO Dressing Protect CHG Excellent 1st Arm in vitro: CHG 3rd Arm in Vivo Advise Avoid 2018 From PreSurg CHG SP Antisepsis Pen Edge Tegaderm CHG Pen 10 min Tegaderm BO Curr Eye Res 3 Arms to Experiment Standard Concentrate At 5 min Water Never Pen Dressing with 2–4% Water No Pen with Tegaderm CHGHCG Result Ocular Injury Tegaderm Even with BO Conclusion Use Dressing- Tegaderm 2nd Arm Tegaderm Perm PI Prep to Closed Eye Central Perm Edges to CHG Not Tegaderm Water Impermeable to both CHG and Water at 90 min Ghobrial et al.[4] Preop SP CHG versus PI Compare Efficacy 2011–2015 SSI Pts No Significant 2018 6959 Consecutive Spinal SP SSI DD 48/69 Differences in J Neurosurg Surgery Pt ChloraPrep 2 (0.1%) MIS/885 IF in 51/69 Index 1st SSI PI 33 versus Spine CHGHCG versus PI Cases Surgery CHGHCG to Reduce SSI 1.1% Open 67 of 6074 38 RS Chloraprep 36 Cases Shive et al.[7] Use of CHG SP Head/ Review PubMed 14 Cases Hearing Loss 38 Cases Eye Tox- 38 Cases Eye Tox- 2021 Neck Web of Science CHG/Ear 8 Direct Install Dermatol Surg Review Tox Ears/Eyes 38 Cases Eye Tox- 17 Periocular 7 Prep of Face Surgical Prep 1 Scalp (remaining prep less 2 Drips Distant defined) Sites 3 Not specified Ker: Keratitis, Presurg: Presurgical, CI: Corneal injury, SP: Skin preparation, SC: Skin cleanser, CHG: ChlorHexidine gluconate, Sig: Significant, CD: Corneal damage,