- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01341041
Chlorine Dioxide Versus Saline for Wound Irrigation
April 21, 2011 updated by: Rhode Island Hospital
Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chlorine dioxide
2 arms
|
one time wash with 50ppm CD solution
|
Active Comparator: saline
one time wash with 50-100cc of normal saline
|
one time wash with 50-100 cc normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cosmesis
Time Frame: 72 hrs post-ED visit
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
April 11, 2011
First Submitted That Met QC Criteria
April 21, 2011
First Posted (Estimate)
April 25, 2011
Study Record Updates
Last Update Posted (Estimate)
April 25, 2011
Last Update Submitted That Met QC Criteria
April 21, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0334-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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