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Efficacy of a Fibrin Sealant in Burn Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181974
First Posted: September 16, 2005
Last Update Posted: October 24, 2012
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.
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
Robert L. Sheridan, Massachusetts General Hospital
  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
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00181974


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

Responsible Party: Robert L. Sheridan, Surgeon, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181974     History of Changes
Other Study ID Numbers: Not sponsored
First Submitted: September 14, 2005
First Posted: September 16, 2005
Last Update Posted: October 24, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Fibrin Tissue Adhesive
Hemostatics
Coagulants