Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
Phase 2
Completed
- Conditions
- Surgical Hemostasis
- Interventions
- Biological: rThrombin
- Registration Number
- NCT00371215
- Lead Sponsor
- ZymoGenetics
- Brief Summary
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.
- Detailed Description
This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury
Exclusion Criteria
- Known antibodies or hypersensitivity to thrombin or other coagulation factors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 rThrombin rThrombin
- Primary Outcome Measures
Name Time Method The incidence and severity of adverse events Up to day 29
- Secondary Outcome Measures
Name Time Method The incidence and grade of clinical laboratory abnormalities Up to day 29 The incidence of anti-rThrombin product antibodies Up to day 29 The incidence of hemostasis Up to 20 minutes The percentage of graft take Up to day 29 The incidence of re-grafting Up to day 29
Trial Locations
- Locations (1)
Richard M. Fairbanks Burn Center, Wishard Hospital
🇺🇸Indianapolis, Indiana, United States