THE SAFETY AND EFFECTIVENESS OF STERILE HYPOCHLOROUS ACID USED AS SURGICAL IRRIGATION SOLUTION TO REDUCE POSTOPERATIVE COMPLICATIONS: A SYSTEMATIC REVIEW AND META-ANALYSIS
Author(s)
Don Ayers, MASc1, Paul niklewski, PhD2, Evelyn J. Rizzo, MSc3, Robert Bilkovski, MD, MBA4;
1Reveal HEOR, Las Vegas, NV, USA, 2University of Cincinnati, Department of Pharmacology and Neurobiology, Cincinnati, OH, USA, 3Mobility HEOR, AKRON, OH, USA, 4RNB Ventures Consulting, Inc., Tampa, FL, USA
1Reveal HEOR, Las Vegas, NV, USA, 2University of Cincinnati, Department of Pharmacology and Neurobiology, Cincinnati, OH, USA, 3Mobility HEOR, AKRON, OH, USA, 4RNB Ventures Consulting, Inc., Tampa, FL, USA
OBJECTIVES: The objective of this systematic literature review was to determine the safety and effectiveness of sterile hypochlorous acid (HOCl) surgical irrigation solution compared to alternative treatments. A secondary objective was to provide a baseline assessment of surgical irrigation treatments used in a sterile operating room environment.
METHODS: A literature search was performed within the PubMed and EMBASE databases for a period of 2009 to 2024. Surgical irrigation solutions or procedures found were sorted into 5 categories: HOCl, antiseptic/disinfectants, basic irrigation agents, protocols/procedures (non-agent descriptions), and antibiotics. Likewise, surgical procedures were grouped when more than one procedure of the same type was performed. AI-assisted quantitative synthesis technology was utilized for summary statistics and network meta-analysis (NMA) outputs. Meta-analytical regression statistical analyses were preformed using R (version 4.5.1), with two-sided p-values <0.05 considered statistically significant.
RESULTS: Eighty-one studies, 13 of which reported HOCl as the primary intervention, were included for final meta-analysis, and 46 studies for subgroup analysis in abdominal surgery. The most common reported outcome was surgical site infection (SSI). The overall NMA showed that SSI odds were nearly twice as likely (OR 1.97, (95% CI [1.13, 3.44])) for basic irrigation than that of HOCl, ranking HOCl second only to antibiotics in SSI reduction. A pairwise, study-level, meta-analytical regression of abdominal subgroup studies, directly comparing HOCl irrigation with other surgical irrigation agents demonstrated a statistically significant reduction (p=0.010) in SSI risk. Across eleven contrasts, HOCl reduced the odds of SSI by approximately 50% relative to basic irrigation or non-agent protocols.
CONCLUSIONS: These findings indicate that sterile HOCl irrigation provides a safe, consistent, statistically, and both clinically meaningful reduction in SSI risk compared with basic irrigation and non-agent irrigation protocols, without prolonging hospitalization. Additional studies are warranted to validate this report as the magnitude of benefit may vary by intervention type and surgical context.
METHODS: A literature search was performed within the PubMed and EMBASE databases for a period of 2009 to 2024. Surgical irrigation solutions or procedures found were sorted into 5 categories: HOCl, antiseptic/disinfectants, basic irrigation agents, protocols/procedures (non-agent descriptions), and antibiotics. Likewise, surgical procedures were grouped when more than one procedure of the same type was performed. AI-assisted quantitative synthesis technology was utilized for summary statistics and network meta-analysis (NMA) outputs. Meta-analytical regression statistical analyses were preformed using R (version 4.5.1), with two-sided p-values <0.05 considered statistically significant.
RESULTS: Eighty-one studies, 13 of which reported HOCl as the primary intervention, were included for final meta-analysis, and 46 studies for subgroup analysis in abdominal surgery. The most common reported outcome was surgical site infection (SSI). The overall NMA showed that SSI odds were nearly twice as likely (OR 1.97, (95% CI [1.13, 3.44])) for basic irrigation than that of HOCl, ranking HOCl second only to antibiotics in SSI reduction. A pairwise, study-level, meta-analytical regression of abdominal subgroup studies, directly comparing HOCl irrigation with other surgical irrigation agents demonstrated a statistically significant reduction (p=0.010) in SSI risk. Across eleven contrasts, HOCl reduced the odds of SSI by approximately 50% relative to basic irrigation or non-agent protocols.
CONCLUSIONS: These findings indicate that sterile HOCl irrigation provides a safe, consistent, statistically, and both clinically meaningful reduction in SSI risk compared with basic irrigation and non-agent irrigation protocols, without prolonging hospitalization. Additional studies are warranted to validate this report as the magnitude of benefit may vary by intervention type and surgical context.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO116
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy, Performance-based Outcomes
Disease
SDC: Infectious Disease (non-vaccine), SDC: Injury & Trauma, STA: Surgery