Trials / Completed
CompletedNCT01268189
Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- United States Army Institute of Surgical Research · Federal
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean healing time for wounds treated with the OxyBand dressing will be less than the mean healing time for wounds treated with the Xeroform dressing.
Detailed description
Patients who are scheduled for excision of burns or other injuries will have one of two donor sites covered with the OxyBand Dressing, and the other treated according to standard of care. OxyBand is an FDA (Food and Drug Administration) approved (K043063) wound dressing for delivery of oxygen into the wound. Two small clinical studies using OxyBand have been conducted on standardized laser burn wounds, demonstrating faster healing time compared to a placebo. No studies have compared this dressing to Xeroform dressing, the standard dressing used on donor sites in the USAISR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Oxygen diffusing dressing | Oxygen diffusing dressing applied to study wound |
| DEVICE | Standard of care dressing | Xeroform control dressing applied to control wound |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2010-12-29
- Last updated
- 2015-10-09
- Results posted
- 2015-10-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01268189. Inclusion in this directory is not an endorsement.