Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone

Overview

The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.

Full Title of Study: “Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2009

Detailed Description

A topical antimicrobial that decrease the bacterial bioburden of surgical wounds without impairing the wound's ability to heal is a need. A stabilized form of hypochlorous acid has been demonstrated in vitro and in animal studies to possess properties that could fulfill these criteria but it is imperative to assess its efficacy and safety in humans. To assess hypochlorous acid efficacy and safety, it was designed a clinical controlled randomized trial to compare hypochlorous acid to iodopovidone, the gold standard, in preoperative scrub of surgical area.

Interventions

  • Drug: Hypochlorous acid
    • Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray
  • Drug: Iodopovidone
    • Iodopovidone

Arms, Groups and Cohorts

  • Experimental: A
    • Hypochlorous acid
  • Active Comparator: B
    • Iodopovidone

Clinical Trial Outcome Measures

Primary Measures

  • Surgical site infection rates
    • Time Frame: until one month (weekly)

Secondary Measures

  • Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site
    • Time Frame: one week

Participating in This Clinical Trial

Inclusion Criteria

  • All patients over 18 years old, who are going to be operated – Classification of surgical wounds according to the National Research Council as class I or II – Risk index classification of the American Society of Anaesthesiology (ASA) as ASA 1 or 2 Exclusion Criteria:

  • Patients requiring mesh or prosthesis or orthesis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Tecnológica de Pereira
  • Collaborator
    • Hospital Universitario San Jorge de Pereira (HUSJ)
  • Provider of Information About this Clinical Study
    • Juliana Buitrago Jaramillo, Universidad Tecnológica de Pereira
  • Overall Official(s)
    • Juliana Buitrago, MD.,MSc, Principal Investigator, Universidad Tecnológica de Pereira
  • Overall Contact(s)
    • Juliana Buitrago, Master, 313-649-0439, julianabuitrago@yahoo.com

References

Selkon JB, Cherry GW, Wilson JM, Hughes MA. Evaluation of hypochlorous acid washes in the treatment of chronic venous leg ulcers. J Wound Care. 2006 Jan;15(1):33-7. doi: 10.12968/jowc.2006.15.1.26861.

Robson MC, Payne WG, Ko F, Mentis M, Donati G, Shafii SM, Culverhouse S, Wang L, Khosrovi B, Najafi R, Cooper DM, Bassiri M. 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 Apr 11;6:e6.

Wang L, Bassiri M, Najafi R, Najafi K, Yang J, Khosrovi B, Hwong W, Barati E, Belisle B, Celeri C, Robson MC. 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 Apr 11;6:e5.

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