Efficacy of a Fibrin Sealant in Burn Surgery

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00181974
• Collaborator: Shriners Hospitals for Children (Other)
• Enrollment: 25
• Location: 1
• Duration (Months): 92
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2000
• Actual Primary Completion Date: Feb 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert L. Sheridan, Surgeon, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00181974
• Other Study ID Numbers: Not sponsored
• First Posted: Sep 16, 2005
• Last Update Posted: Oct 24, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Robert L. Sheridan, Surgeon, Massachusetts General Hospital: burns; hemostasis; skin graft; Surgical Hemostasis; Grafting, Skin
• Additional relevant MeSH terms: Burns; Fibrin Tissue Adhesive

Study Results

No Results Posted as of Oct 24, 2012