Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone
- Registration Number
- NCT00692757
- Lead Sponsor
- Universidad TecnolĂłgica de Pereira
- Brief Summary
The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 432
- 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
- Patients requiring mesh or prosthesis or orthesis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Iodopovidone Iodopovidone A Hypochlorous acid Hypochlorous acid
- Primary Outcome Measures
Name Time Method Surgical site infection rates until one month (weekly)
- Secondary Outcome Measures
Name Time Method Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site one week
Trial Locations
- Locations (1)
Hospital Universitario San Jorge (HUSJ)
🇨🇴Pereira, Risaralda, Colombia