Expired Study
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Boston, Massachusetts 02114


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.


Study summary:

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: 1. as a hemostatic agent on excised burns, 2. as a hemostatic agent on donor sites, and 3. 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: 1. discomfort upon removal and 2. 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.


Criteria:

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.


NCT ID:

NCT00181974


Primary Contact:

Principal Investigator
Robert L Sheridan, M.D.
Shriners Burns Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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