Clinical trial NCT00692757: Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone
Official title: Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Surgical Site Infection
Keywords: Hypochlorous Acid
Colony forming units
surgical site infection
nosocomial infection
bacterial bioburden
wound healing
Lead sponsor: Universidad Tecnológica de Pereira
Sponsor class: OTHER
Collaborators: name: Hospital Universitario San Jorge de Pereira (HUSJ)
First posted: 2008-06-06
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical site infection rates
timeFrame: until one month (weekly)
Secondary outcomes:
measure: Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site
timeFrame: one week
Other outcomes:
Locations:
city: Pereira
country: Colombia
facility: Hospital Universitario San Jorge (HUSJ)
state: Risaralda
Study officials:
affiliation: Universidad Tecnológica de Pereira
name: Juliana Buitrago, MD.,MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.