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. Identifier: NCT00181974
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 24, 2012
Shriners Hospitals for Children
Information provided by (Responsible Party):
Robert L. Sheridan, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Burns Drug: Tisseel Fibrin Sealant Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Primary Outcome Measures :
  1. initial wound hemostasis
  2. initial donor site hemostasis
  3. initial graft fixation
  4. percent graft take at 1 week
  5. outcome and cosmetic appearance at routine intervals up to 24 months

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

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 identifier (NCT number): 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

Responsible Party: Robert L. Sheridan, Surgeon, Massachusetts General Hospital Identifier: NCT00181974     History of Changes
Other Study ID Numbers: Not sponsored
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 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