Hemostatic Textile to Control Bleeding at Donor Graft Sites (Stasilon)
The rationale underlying the study is that donor site bleeding is common and often problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings are not sufficiently hemostatic to control a donor site bleed thereby leading to administration of vasoconstrictive agents and repeated application of wound dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also, observational case reports have noted cessation of bleeding in a limited number of human patients with difficult to control bleeds.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Use of a HemostaticTextile (StasilonTM) to Control Bleeding at Skin Graft Donor Sites (Randomized, Single-Blind)|
- To compare the efficacy of a new hemostatic textile named Stasilon™ against standard wound dressings in controlling burn patient donor graft site bleeding. [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made
Stasilon and gauze will be applied to donor site. Dressings will be collected and evaluated for amount of shed blood.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855569
|United States, North Carolina|
|North Carolina Jaycee Burn Center|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Preston Rich, MD||University of North Carolina, Chapel Hill|