Efficacy of a Fibrin Sealant in Burn Surgery

This study has been completed.
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
Robert L. Sheridan, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181974
First received: September 14, 2005
Last updated: October 22, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 August 18, 2014