Wound - in Medical Care
Conditions
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.
Interventions
BIOLOGICALchlorine dioxide
one time wash with 50ppm CD solution
BIOLOGICALsaline
one time wash with 50-100 cc normal saline
Sponsors
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cosmesis | 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. |
Countries
United States
Outcome results
None listed