Efficacy of a Fibrin Sealant in Burn Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00181974|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Burns||Drug: Tisseel Fibrin Sealant||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a Fibrin Sealant in Burn Surgery|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||November 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181974
|United States, Massachusetts|
|Shriners Burns Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Robert L Sheridan, M.D.||Shriners Burns Hospital|