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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 11, 2011
Last Updated Date	April 21, 2011
Start Date ^ICMJE	August 2004
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 21, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01341041 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Chlorine Dioxide Versus Saline for Wound Irrigation
Official Title ^ICMJE	Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 0
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Wound - in Medical Care
Intervention ^ICMJE	Biological: chlorine dioxide one time wash with 50ppm CD solution Biological: saline one time wash with 50-100 cc normal saline
Study Arm (s)	Experimental: chlorine dioxide 2 arms Intervention: Biological: chlorine dioxide Active Comparator: saline one time wash with 50-100cc of normal saline Intervention: Biological: saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	201
Completion Date	June 2009
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01341041
Other Study ID Numbers ^ICMJE	0334-03
Has Data Monitoring Committee	Not Provided
Responsible Party	Jonathan Valente MD, Rhode Island Hospital
Study Sponsor ^ICMJE	Rhode Island Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Rhode Island Hospital
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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