Evaluation of Dermafill Dressing for Donor Sites
The purpose of the study is to compare one type of dressing against the current standard dressing that is used to cover the unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.
Hypothesis: The mean healing time for wounds treated with the Dermafill dressing will be less than the mean healing time for wounds treated with Xeroform dressing.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Dermafill Dressing for Autogenous Skin Donor Sites|
- Pain will be less or equal to with the Dermafill dressing as compared with Xeroform
- Cosmetic effect of healing at post surgery day 30-60 will be equal or less with Dermafill as compared with Xeroform
- Infections associated with donor sites will be equal to or less with Dermafill as compared with Xeroform
|Study Start Date:||March 2005|
|Study Completion Date:||March 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. The donor sites will be harvested. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Dermafill dressing or Xeroform. The wound dressings will then be observed at least once a day beginning post op day 2/48hours after surgery until healed, which is defined as 90% or more of the wound surface is confluently re-epithelized.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137163
|United States, Texas|
|US Army Institute of Surgical Research|
|Fort Sam Houston, Texas, United States, 78234-6315|
|Principal Investigator:||Michael Albrecht, MD||US Army Institute of Surgical Research|