Clinical trial NCT01268189: Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds
Official title: Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: burn wound
management with oxygen
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2010-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Healing Time for Donor Site Wounds
timeFrame: number of days to healing
Secondary outcomes:
measure: Pain Perceived by Patient
timeFrame: Post-Operative Day 4
measure: Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
timeFrame: Post-Operative Day 8
measure: Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
timeFrame: Post-Operative Day 10
measure: Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
timeFrame: Post-Operative Day 12
Other outcomes:
Locations:
city: Ft. Sam Houston
country: United States
facility: US Army Institute of Surgical Research, Burn Center
state: Texas
Study officials:
affiliation: US Army Institute of Surgical Research
name: Kimberly F Lairet, MD
role: PRINCIPAL_INVESTIGATOR
References: