Efficacy of a Fibrin Sealant in Burn Surgery

Burns Clinical Trial

Official title:

Efficacy of a Fibrin Sealant in Burn Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181974
• Other study ID #: Not sponsored
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: October 22, 2012
• Start date: March 2000
• Est. completion date: November 2007

Study information

• Verified date: October 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Tisseel Fibrin Sealant

Locations

Country	Name	City	State
United States	Shriners Burns Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	initial wound hemostasis
Primary	initial donor site hemostasis
Primary	initial graft fixation
Primary	percent graft take at 1 week
Primary	outcome and cosmetic appearance at routine intervals up to 24 months