Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites
The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an 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 Silverlon 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 Silverlon Dressing for Autogenous Skin Donor Sites|
- Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Cosmetic effect of healing at post operative day 30-45 will be equal to or less than with Silverlon as compared with Xeroform [ Time Frame: 30-45 days ] [ Designated as safety issue: No ]
- Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform [ Time Frame: 14 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
dressing for donor site mamagement
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Silverlon dressing or Xeroform. The wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137215
|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|
|Study Director:||Steven E Wolf, MD||US Army Institute of Surgical Research|