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Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone (WASH)

Primary Purpose

Surgical Site Infection

Status
Unknown status
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
Hypochlorous acid
Iodopovidone
Sponsored by
Universidad Tecnológica de Pereira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Hypochlorous Acid, Colony forming units, surgical site infection, nosocomial infection, bacterial bioburden, wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario San Jorge (HUSJ)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Hypochlorous acid

Iodopovidone

Outcomes

Primary Outcome Measures

Surgical site infection rates

Secondary Outcome Measures

Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site

Full Information

First Posted
June 3, 2008
Last Updated
October 20, 2008
Sponsor
Universidad Tecnológica de Pereira
Collaborators
Hospital Universitario San Jorge de Pereira (HUSJ)
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1. Study Identification

Unique Protocol Identification Number
NCT00692757
Brief Title
Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone
Acronym
WASH
Official Title
Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Tecnológica de Pereira
Collaborators
Hospital Universitario San Jorge de Pereira (HUSJ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Hypochlorous Acid, Colony forming units, surgical site infection, nosocomial infection, bacterial bioburden, wound healing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Hypochlorous acid
Arm Title
B
Arm Type
Active Comparator
Arm Description
Iodopovidone
Intervention Type
Drug
Intervention Name(s)
Hypochlorous acid
Other Intervention Name(s)
NVC-101 NovaBay Pharmaceuticals, Inc, Emeryville, CA
Intervention Description
Hypochlorous acid for preoperative scrubbing to prevent surgical site infection in spray
Intervention Type
Drug
Intervention Name(s)
Iodopovidone
Intervention Description
Iodopovidone
Primary Outcome Measure Information:
Title
Surgical site infection rates
Time Frame
until one month (weekly)
Secondary Outcome Measure Information:
Title
Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana Buitrago, Master
Phone
313-649-0439
Email
julianabuitrago@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Buitrago, MD.,MSc
Organizational Affiliation
Universidad Tecnológica de Pereira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario San Jorge (HUSJ)
City
Pereira
State/Province
Risaralda
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodolfo A Cabrales, MD.
Phone
57-6-333-0014
Email
rocabster@gmail.com
First Name & Middle Initial & Last Name & Degree
German A Moreno, MD.,MSc
Phone
57-6-333-7126
Email
gamo@cable.net.co
First Name & Middle Initial & Last Name & Degree
Rodolfo A Cabrales, MD.

12. IPD Sharing Statement

Citations:
PubMed Identifier
16669304
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.
Results Reference
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PubMed Identifier
17492051
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.
Results Reference
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PubMed Identifier
17492050
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.
Results Reference
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Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone

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