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Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone (WASH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Universidad Tecnológica de Pereira.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: June 6, 2008
Last Update Posted: October 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Hospital Universitario San Jorge de Pereira (HUSJ)
Information provided by:
Universidad Tecnológica de Pereira
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
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

Further study details as provided by Universidad Tecnológica de Pereira:

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

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

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
Drug: 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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

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

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)
Principal Investigator: Juliana Buitrago, MD.,MSc Universidad Tecnológica de Pereira
  More Information

Responsible Party: Juliana Buitrago Jaramillo, Universidad Tecnológica de Pereira
ClinicalTrials.gov Identifier: NCT00692757     History of Changes
Other Study ID Numbers: 5-07-9
First Submitted: June 3, 2008
First Posted: June 6, 2008
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:
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents, Local
Anti-Infective Agents