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Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone (WASH)

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ClinicalTrials.gov Identifier: NCT00692757
Recruitment Status : Unknown
Verified October 2008 by Universidad Tecnológica de Pereira.
Recruitment status was:  Recruiting
First Posted : June 6, 2008
Last Update Posted : October 21, 2008
Sponsor:
Collaborator:
Hospital Universitario San Jorge de Pereira (HUSJ)
Information provided by:
Universidad Tecnológica 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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Hypochlorous acid Drug: Iodopovidone Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection
Study Start Date : July 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Surgical site infection rates [ Time Frame: until one month (weekly) ]

Secondary Outcome Measures :
  1. Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site [ Time Frame: one week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Juliana Buitrago Jaramillo, Universidad Tecnológica de Pereira
ClinicalTrials.gov Identifier: NCT00692757     History of Changes
Other Study ID Numbers: 5-07-9
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008

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:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents, Local
Anti-Infective Agents