Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds|
- Healing Time for Donor Site Wounds [ Time Frame: number of days to healing ] [ Designated as safety issue: No ]Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.
- Pain Perceived by Patient [ Time Frame: Post-Operative Day 4 ] [ Designated as safety issue: No ]Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.
- Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site [ Time Frame: Post-Operative Day 8 ] [ Designated as safety issue: No ]
- Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site [ Time Frame: Post-Operative Day 10 ] [ Designated as safety issue: No ]
- Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site [ Time Frame: Post-Operative Day 12 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: Burn wound patients with donor sites
Oxygen diffusing dressing applied to wound vs standard of care dressing (Xeroform) applied to wound (patient serves as own control as s/he receives 1 dressing on 1 donor site and the other on a 2nd donor site)
Device: Oxygen diffusing dressing
Oxygen diffusing dressing applied to study wound
Other Name: OxyBand dressingDevice: Standard of care dressing
Xeroform control dressing applied to control wound
Other Name: Xeroform dressing
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268189
|United States, Texas|
|US Army Institute of Surgical Research, Burn Center|
|Ft. Sam Houston, Texas, United States, 78234|
|Principal Investigator:||Kimberly F Lairet, MD||US Army Institute of Surgical Research|