The topic of breast implant pocket irrigation has been addressed in literally dozens of published studies, reviews, invited discussions, and/or letters to the editor in just the last several years. Adding to that body of literature is this current in vitro study1 from some members of a research group that has previously provided some of the most significant microbiology research findings in breast implant surgery.2-6 The authors of this study are to be commended for attempting to add to our knowledge base on the potential effectiveness of povidone iodine (Betadine) and stabilized hypochlorous acid (PhaseOne). Povidone iodine (Betadine) has been used in breast implant surgery for decades in an effort to reduce capsular contracture, either as an irrigant for the surgical pocket and/or to soak the implant prior to insertion. It remains a current practice as evidenced in three recently published surveys.7-9 Originally discovered by a toxicologist in 1949,10 povidone iodine is on the World Health Organization’s list of essential medicines,11 and is widely recognized to provide the well-documented antimicrobial benefits of iodine while significantly limiting toxicity. A recent systematic review and meta-analysis by Yalanis and colleagues12 of povidone-iodine irrigation for reducing the risk of capsular contracture in breast augmentation (updated further by Cheng13) did conclude that irrigation with povidone iodine reduces Baker class III/ IV capsular contracture, however, they noted that the underlying studies were of low methodologic quality which “limits recommendations for perioperative povidone iodine irrigation as the standard of practice” and that further studies of high quality are needed. Hypochlorous acid, and specifically PhaseOne,14,15 is a more recently introduced broad spectrum antiseptic which is formulated to provide stabilization and maximal antimicrobial activity. As was noted in this study, hypochlorous acid has long been recognized as an endogenous antimicrobial substance in the human body produced by activated neutrophils. The stabilized form of hypochlorous acid present in PhaseOne also has been demonstrated to exhibit greater antimicrobial activity at levels that are noncytotoxic to fibroblasts as compared to other commonly used skin, wound, and skin/wound cleansers16—as might be expected for an endogenously produced substance, and is also seemingly without reports of any allergic reactions. This study illustrates a common dilemma in research of this type. There is significant benefit, where possible and appropriate, of using standardized methods for evaluating the efficacy of antimicrobials;17 however, it is also critical to ensure that any standardized test methods employed are directly relevant to and representative of real world conditions. The current study does not appear to have succeeded in this latter regard. The PhaseOne stabilized hypochlorous acid product (consistent with labeling) is normally used undiluted, while in the minimum inhibitory concentration (MIC), minimum eradication concentration (MEC), minimum biofilm inhibition concentration (MBIC), and minimum biofilm eradication concentration (MBEC) assays involving Staph. aureus in this study, the product was diluted such that the maximum concentration was half-strength and thus not representative of actual use conditions. Perhaps more significant, particularly in light of the known mechanism of action of hypochlorous acid, the amount of added protein present in: the MIC/MEC/MBIC/MBEC assays with 50% tryptone soy broth; the MBEC device assay when performed in the presence of 5% bovine calf serum; the efficacy against 3-day yydrated biofilm assay when performed in the presence of 5% bovine calf serum; and the breast implant attachment assay when performed in the presence of 5% bovine calf serum, all vastly exceed the amount of protein actually present in the breast surgical pocket immediately prior to implant insertion, based on actual measurements in surgical pockets as cited by Fisher and colleagues.18 The presence of such a large excess of protein is known to inactivate hypochlorous acid via its rapid consumption by oxidation reactions, thereby significantly reducing its antimicrobiocidal activity.19 It is interesting to note in this study that in the absence of dilution and or addition of excess protein: both PhaseOne and Betadine were highly effective in eradicating S. aureus biofilm bacteria in the MBEC device assay after 15 minutes and 24 hours contact time; both PhaseOne and Betadine were entirely effective at eliminating 3-day hydrated biofilms of S. aureus after 15 minutes contact time; and both PhaseOne and Betadine were entirely effective at eliminating S. aureus in the breast implant attachment assay after 15 minutes. The findings from this study that involved dilution or addition of protein would not seem to provide any directly relevant comparative guidance related to actual conditions typically encountered during breast implant surgery. With the increasing recent focus in both the literature and at plastic surgery conferences on the use of povidone iodine (Betadine) in breast implant surgery, it is perhaps worth reiterating the caution identified by Hall-Findlay and colleagues20 regarding the potential incompatibility of Betadine mixed with Marcaine for pocket irrigation. Although in vitro and animal studies can both provide some potentially meaningful evidence to assist in clinical decision making, Level I evidence from randomized controlled trials (RCTs) is certainly to be preferred. The ongoing RCT by Myckatyn and colleagues (ClinicalTrials.gov NCT03213249) comparing intraoperative pocket irrigation with saline vs triple antibiotic without betadine in two-stage expander implant breast reconstruction is a clear example of what is needed to definitively resolve ongoing debates on antimicrobial approaches. It is hoped that further RCTs with expanded antimicrobial options including antiseptics will be pursued in the immediate future. Results from such studies, perhaps together with data from further in vitro and animal studies that strive to reproduce to the extent possible actual conditions in primary and revision breast surgery, will hopefully better inform surgeons’ selection of antimicrobial options. Disclosures The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. Funding The author received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Hu H , Sleiman J , Johani K , Vickery K . Hypochlorous acid versus povidone-iodine containing irrigants: which antiseptic is more effective for breast implant pocket irrigation ? Aesthet Surg J . 2017 . doi: 10.1093/asj/sjx213 . [Epub ahead of print] 2. Pajkos A , Deva AK , Vickery K , Cope C , Chang L , Cossart YE . Detection of subclinical infection in significant breast implant capsules . Plast Reconstr Surg . 2003 ; 111 ( 5 ): 1605 - 1611 . Google Scholar CrossRef Search ADS PubMed 3. Tamboto H , Vickery K , Deva AK . Subclinical (biofilm) infection causes capsular contracture in a porcine model following augmentation mammaplasty . Plast Reconstr Surg . 2010 ; 126 ( 3 ): 835 - 842 . Google Scholar CrossRef Search ADS PubMed 4. Hu H , Jacombs A , Vickery K , Merten SL , Pennington DG , Deva AK . Chronic biofilm infection in breast implants is associated with an increased T-cell lymphocytic infiltrate: implications for breast implant-associated lymphoma . Plast Reconstr Surg . 2015 ; 135 ( 2 ): 319 - 329 . Google Scholar CrossRef Search ADS PubMed 5. Hu H , Johani K , Almatroudi A et al. Bacterial biofilm infection detected in breast implant-associated anaplastic large-cell Lymphoma . Plast Reconstr Surg . 2016 ; 137 ( 6 ): 1659 - 1669 . Google Scholar CrossRef Search ADS PubMed 6. Loch-Wilkinson A , Beath KJ , Knight RJW et al. Breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: high-surface-area textured implants are associated with increased risk . Plast Reconstr Surg . 2017 ; 140 ( 4 ): 645 - 654 . Google Scholar CrossRef Search ADS PubMed 7. Chopra K , Gowda AU , McNichols CHL , Brown EN , Slezak S , Rasko Y . Antimicrobial prophylaxis practice patterns in breast augmentation: a national survey of current practice . Ann Plast Surg . 2017 ; 78 ( 6 ): 629 - 632 . Google Scholar CrossRef Search ADS PubMed 8. Gowda AU , Chopra K , Brown EN , Slezak S , Rasko Y . Preventing breast implant contamination in breast reconstruction: a national survey of current practice . Ann Plast Surg . 2017 ; 78 ( 2 ): 153 - 156 . Google Scholar CrossRef Search ADS PubMed 9. Heidekrueger PI , Sinno S , Hidalgo DA , Colombo M , Broer PN . Current trends in breast augmentation: an international analysis . Aesthet Surg J . 2018 ; 38 ( 2 ): 133 - 148 . Google Scholar CrossRef Search ADS PubMed 10. Anonymous . New iodine compound is internal antiseptic . Chem Eng News . 1951 ; 29 ( 8 ): 664 . 11. World Health Organization . WHO Model List of Essential Medicines . World Health Organization website. http://www.who.int/medicines/publications/essentialmedicines/20th_EML2017_FINAL_amendedAug2017.pdf. March 2017 . Updated August 2017. Accessed February 3, 2018 . 12. Yalanis GC , Liu EW , Cheng HT . Efficacy and safety of povidone-iodine irrigation in reducing the risk of capsular contracture in aesthetic breast augmentation: a systematic review and meta-analysis . Plast Reconstr Surg . 2015 ; 136 ( 4 ): 687 - 698 . Google Scholar CrossRef Search ADS PubMed 13. Cheng HT . Reply: efficacy and safety of povidone-iodine irrigation in reducing the risk of capsular contracture in aesthetic breast augmentation: a systematic review and meta-analysis . Plast Reconstr Surg . 2016 ; 138 ( 2 ): 369e - 370e . Google Scholar CrossRef Search ADS PubMed 14. Wang L , Bassiri M , Najafi R et al. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity . J Burns Wounds . 2007 ; 6 : e5 . Google Scholar PubMed 15. Robson MC , Payne WG , Ko F et al. hypochlorous acid as a potential wound care agent: part ii. stabilized hypochlorous acid: its role in decreasing tissue bacterial bioburden and overcoming the inhibition of infection on wound healing . J Burns Wounds . 2007 ; 6 : e6 . Google Scholar PubMed 16. Rani SA , Hoon R , Najafi RR , Khosrovi B , Wang L , Debabov D . The in vitro antimicrobial activity of wound and skin cleansers at nontoxic concentrations . Adv Skin Wound Care . 2014 ; 27 ( 2 ): 65 - 69 . Google Scholar CrossRef Search ADS PubMed 17. Malone M , Goeres DM , Gosbell I , Vickery K , Jensen S , Stoodley P . Approaches to biofilm-associated infections: the need for standardized and relevant biofilm methods for clinical applications . Expert Rev Anti Infect Ther . 2017 ; 15 ( 2 ): 147 - 156 . Google Scholar CrossRef Search ADS PubMed 18. Fisher J , Brindle T , Porter S . The importance of clinically relevant research when making comparisons . Aesthet Surg J . 2018 ; 38 ( 4 ): NP76 - NP78 . Google Scholar CrossRef Search ADS PubMed 19. Ishihara M , Murakami K , Fukuda K et al. Stability of weakly acidic hypochlorous acid solution with microbicidal activity . Biocontrol Sci . 2017 ; 22 ( 4 ): 223 - 227 . Google Scholar CrossRef Search ADS PubMed 20. Hall-Findlay EJ , Strong B , Edgar P . Incompatibility of betadine mixed with marcaine as an irrigant for breast implant pockets . Plast Reconstr Surg . 2013 ; 131 ( 2 ): 299e - 300e . Google Scholar CrossRef Search ADS PubMed © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: firstname.lastname@example.org This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)
Aesthetic Surgery Journal – Oxford University Press
Published: May 14, 2018
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