Efficacy of a Fibrin Sealant in Burn Surgery
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Purpose
The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.
| Condition | Intervention |
|---|---|
|
Burns |
Drug: Tisseel Fibrin Sealant |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 25 |
| 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Requires skin grafting of an acute or reconstructive burn wound.
Exclusion Criteria:
- Active disseminated intravascular coagulation (DIC) or known hypersensitivity to bovine protein.
Contacts and Locations| United States, Massachusetts | |
| Shriners Burns Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Robert L Sheridan, M.D. | Shriners Burns Hospital |
More Information
No publications provided
| Responsible Party: | Robert L. Sheridan, Surgeon, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00181974 History of Changes |
| Other Study ID Numbers: | Not sponsored |
| Study First Received: | September 14, 2005 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
burns hemostasis skin graft Surgical Hemostasis Grafting, Skin |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Fibrin Tissue Adhesive Hemostatics |
Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013