Chlorine Dioxide Versus Saline for Wound Irrigation

This study has been completed.
Sponsor:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01341041
First received: April 11, 2011
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

This research is being done because the investigators are trying to examine the safety and effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are trying to see if this liquid has the ability to decrease infection rates and decrease the scarring effects from the healing process. In animal studies, CACD has been shown to decrease scar formation and decrease the risk of wound infections. CACD is also used for the treatment of burns to decrease infection rates and improve wound healing. CACD is not FDA approved for this specific use, but it is FDA and USDA approved for reducing bacterial contamination on meat and food products for human consumption. In addition, an investigational drug (IND) application has been submitted to the FDA for this study. The FDA has approved the use of this solution for this study.


Condition Intervention Phase
Wound - in Medical Care
Biological: chlorine dioxide
Biological: saline
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • cosmesis [ Time Frame: 72 hrs post-ED visit ] [ Designated as safety issue: Yes ]
    Cosmesis will be assessed by taking pictures of the wound at presentation, upon receiving sutures, 48-72 hrs later, and 3-4 mths later. At 3-4 mths the patient will rate how well they think the wound healed, via a visual analog scale. At that time, two blinded ER physicians will do this as well. They will also designate a wound evaulation score, based on criteria that will be provided to them. Two blinded plastic surgeons will assess all photographs, visual analog scores. and wound evaluation scores, and provide their own visual analog scale assessment of how well each wound healed.


Enrollment: 201
Study Start Date: August 2004
Study Completion Date: June 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chlorine dioxide
2 arms
Biological: chlorine dioxide
one time wash with 50ppm CD solution
Active Comparator: saline
one time wash with 50-100cc of normal saline
Biological: saline
one time wash with 50-100 cc normal saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-100 years old
  • simple laceration requiring irrigation & sutures
  • patient has method of contact
  • patient is willing to return to ED in 3-4 mths

Exclusion Criteria:

  • immunocompromised
  • consult required for repair
  • diabetic
  • require antibiotics
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01341041

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Jonathan Valente MD, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01341041     History of Changes
Other Study ID Numbers: 0334-03
Study First Received: April 11, 2011
Last Updated: April 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chlorine dioxide
Dental Disinfectants
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 09, 2014