N/A
N=20
Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds
Burns
Bottom Line
View on ClinicalTrials.gov: NCT01268189 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Healing Time for Donor Site Wounds — 9.4; 12.4 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Oxygen diffusing dressing (Device); Standard of care dressing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- United States Army Institute of Surgical Research
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Healing Time for Donor Site Wounds |
9.4; 12.4 | — |
| SECONDARY Pain Perceived by Patient |
0.6; 1.6 | — |
| SECONDARY Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site |
0.2; 0.5 | — |
| SECONDARY Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site |
0.2; 0.5 | — |
| SECONDARY Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site |
0.2; 0.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject must be at least 18 years of age; of either gender and in good general health.
- Subject has sustained burn wounds of less than 30 percent of the total body surface area
- Burn wounds do not involve the harvesting area
- Subject has sustained burn wounds that, in the judgment of the attending surgeon, require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surfaces areas
- The scheduled excision and grafting procedure is the first such operation for the subject during this hospitalization
- Subject agrees to participate in follow-up evaluations
Exclusion Criteria
- Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 or requiring vasoactive medications to support blood pressure
- Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- Subjects receiving treatment with medications that inhibit or compromise wound healing. Examples include therapeutic anticoagulants, antiplatelet drugs, and systemic steroids such as warfarin, clopidogrel or prednisone. The use of anticoagulants does not include DVT (Deep Vein Thrombosis) prophylaxis. Subjects may use aspirin or lovenox
- Cellulitis or other infection of the potential donor sites
- Donor site has been previously harvested for grafting
- Subjects with greater than 30% total body surface area burns
- Pregnancy
- Prisoners
Data sourced from ClinicalTrials.gov (NCT01268189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.