Efficacy of a Fibrin Sealant in Burn Surgery
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of a Fibrin Sealant in Burn Surgery|
- initial wound hemostasis
- initial donor site hemostasis
- initial graft fixation
- percent graft take at 1 week
- outcome and cosmetic appearance at routine intervals up to 24 months
|Study Start Date:||March 2000|
|Study Completion Date:||November 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Burn patients require extensive split-thickness skin grafting operations. These operations necessitate excision of burn wounds and the procurement of autografts. Both of these result in bleeding open wounds. Fibrin sealants may be of benefit in three aspects of burn surgery:
- as a hemostatic agent on excised burns,
- as a hemostatic agent on donor sites, and
- as a method of fixation of skin grafts to wounds.
Skin grafts are routinely secured with surgical staples. Patients with large burns will commonly have hundreds, even thousands of staples used during the course of their care. Problems associated with the use of surgical staples include:
- discomfort upon removal and
- staples become deeply embedded in the tissue.
If effective in securing skin grafts, fibrin glue would directly benefit burn patients by decreasing the number of staples required, and thereby decreasing the number of retained staples. Fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma that is virally inactivated by a two-stage heating process.
Subjects will serve as their own control. They will have an area of their wound treated with the fibrin sealant and another area treated with the standard of care. Both areas will be compared for hemostasis, skin graft fixation, wound healing, and cosmetic outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181974
|United States, Massachusetts|
|Shriners Burns Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Robert L Sheridan, M.D.||Shriners Burns Hospital|