Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone (WASH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Universidad Tecnológica de Pereira.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hospital Universitario San Jorge de Pereira (HUSJ)
Information provided by:
Universidad Tecnológica de Pereira
ClinicalTrials.gov Identifier:
NCT00692757
First received: June 3, 2008
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Surgical Site Infection
Drug: Hypochlorous acid
Drug: Iodopovidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection

Further study details as provided by Universidad Tecnológica de Pereira:

Primary Outcome Measures:
  • Surgical site infection rates [ Time Frame: until one month (weekly) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site [ Time Frame: one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 432
Study Start Date: July 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Hypochlorous acid
Drug: Hypochlorous acid
Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray
Other Name: NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CA
Active Comparator: B
Iodopovidone
Drug: Iodopovidone
Iodopovidone

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692757

Contacts
Contact: Juliana Buitrago, Master 313-649-0439 julianabuitrago@yahoo.com

Locations
Colombia
Hospital Universitario San Jorge (HUSJ) Recruiting
Pereira, Risaralda, Colombia
Contact: Rodolfo A Cabrales, MD.    57-6-333-0014    rocabster@gmail.com   
Contact: German A Moreno, MD.,MSc    57-6-333-7126    gamo@cable.net.co   
Sub-Investigator: Rodolfo A Cabrales, MD.         
Sponsors and Collaborators
Universidad Tecnológica de Pereira
Hospital Universitario San Jorge de Pereira (HUSJ)
Investigators
Principal Investigator: Juliana Buitrago, MD.,MSc Universidad Tecnológica de Pereira
  More Information

Publications:
Responsible Party: Juliana Buitrago Jaramillo, Universidad Tecnológica de Pereira
ClinicalTrials.gov Identifier: NCT00692757     History of Changes
Other Study ID Numbers: 5-07-9
Study First Received: June 3, 2008
Last Updated: October 20, 2008
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad Tecnológica de Pereira:
Hypochlorous Acid
Colony forming units
surgical site infection
nosocomial infection
bacterial bioburden
wound healing

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014