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Efficacy of a Fibrin Sealant in Burn Surgery

This study has been completed.
Shriners Hospitals for Children
Information provided by (Responsible Party):
Robert L. Sheridan, Massachusetts General Hospital Identifier:
First received: September 14, 2005
Last updated: October 22, 2012
Last verified: October 2012
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Fibrin Sealant in Burn Surgery

Resource links provided by NLM:

Further study details as provided by Robert L. Sheridan, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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)
Detailed Description:

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00181974

United States, Massachusetts
Shriners Burns Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Shriners Hospitals for Children
Principal Investigator: Robert L Sheridan, M.D. Shriners Burns Hospital
  More Information

Responsible Party: Robert L. Sheridan, Surgeon, Massachusetts General Hospital Identifier: NCT00181974     History of Changes
Other Study ID Numbers: Not sponsored
Study First Received: September 14, 2005
Last Updated: October 22, 2012

Keywords provided by Robert L. Sheridan, Massachusetts General Hospital:
skin graft
Surgical Hemostasis
Grafting, Skin

Additional relevant MeSH terms:
Wounds and Injuries
Fibrin Tissue Adhesive
Coagulants processed this record on September 21, 2017