Chlorine Dioxide Versus Saline for Wound Irrigation
Primary Purpose
Wound - in Medical Care
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
chlorine dioxide
saline
Sponsored by
About this trial
This is an interventional treatment trial for Wound - in Medical Care
Eligibility 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
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
chlorine dioxide
saline
Arm Description
2 arms
one time wash with 50-100cc of normal saline
Outcomes
Primary Outcome Measures
cosmesis
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01341041
Brief Title
Chlorine Dioxide Versus Saline for Wound Irrigation
Official Title
Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound - in Medical Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chlorine dioxide
Arm Type
Experimental
Arm Description
2 arms
Arm Title
saline
Arm Type
Active Comparator
Arm Description
one time wash with 50-100cc of normal saline
Intervention Type
Biological
Intervention Name(s)
chlorine dioxide
Intervention Description
one time wash with 50ppm CD solution
Intervention Type
Biological
Intervention Name(s)
saline
Intervention Description
one time wash with 50-100 cc normal saline
Primary Outcome Measure Information:
Title
cosmesis
Description
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.
Time Frame
72 hrs post-ED visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
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Chlorine Dioxide Versus Saline for Wound Irrigation
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