Hemostatic Textile to Control Bleeding at Donor Graft Sites
Completed
- Conditions
- Wounds
- Interventions
- Device: Stasilon
- Registration Number
- NCT00855569
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- >/= 18 years old
- burn injury requiring allografting from donor site
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Exclusion Criteria
- < 18 years
- unable to give consent due to mental or emotional instability
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Stasilon Each donor site will act as it own control - both dressings will be applied to the donor site and assessments will be made
- Primary Outcome Measures
Name Time Method To compare the efficacy of a new hemostatic textile named Stasilon™ against standard wound dressings in controlling burn patient donor graft site bleeding. At the time of surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
North Carolina Jaycee Burn Center
🇺🇸Chapel Hill, North Carolina, United States