Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone

Surgical Site Infection Clinical Trial

— WASH  

Official title:

Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00692757
• Other study ID #: 5-07-9
• Status: Recruiting
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: October 20, 2008
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2008
• Source: Universidad Tecnológica de Pereira
• Contact: Juliana Buitrago, Master
• Phone: 313-649-0439
• Email: julianabuitrago[@]yahoo.com
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
Colombia	Hospital Universitario San Jorge (HUSJ)	Pereira	Risaralda

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Tecnológica de Pereira	Hospital Universitario San Jorge de Pereira (HUSJ)

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection rates		until one month (weekly)	Yes
Secondary	Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site		one week	No