Chlorine Dioxide Versus Saline for Wound Irrigation
Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution
1 other identifier
interventional
201
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2004
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
April 25, 2011
CompletedApril 25, 2011
April 1, 2011
3.3 years
April 11, 2011
April 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
72 hrs post-ED visit
Study Arms (2)
chlorine dioxide
EXPERIMENTAL2 arms
saline
ACTIVE COMPARATORone time wash with 50-100cc of normal saline
Interventions
Eligibility Criteria
You may qualify if:
- years old
- simple laceration requiring irrigation \& sutures
- patient has method of contact
- patient is willing to return to ED in 3-4 mths
You may not qualify if:
- immunocompromised
- consult required for repair
- diabetic
- require antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 11, 2011
First Posted
April 25, 2011
Study Start
August 1, 2004
Primary Completion
December 1, 2007
Study Completion
June 1, 2009
Last Updated
April 25, 2011
Record last verified: 2011-04