Surgical Hemostasis
Conditions
Keywords
hemostasis, grafting, skin, hemostatics, phase 2
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.
Interventions
BIOLOGICALrThrombin
1000 U/mL applied topically
Sponsors
ZymoGenetics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | Up to day 29 |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of graft take | Up to day 29 |
| The incidence of re-grafting | Up to day 29 |
| 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 |
Countries
United States
Outcome results
None listed