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Efficacy of a Fibrin Sealant in Burn Surgery

Efficacy of a Fibrin Sealant in Burn Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00181974
Enrollment
25
Registered
2005-09-16
Start date
2000-03-31
Completion date
2007-11-30
Last updated
2012-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

burns, hemostasis, skin graft, Surgical Hemostasis, Grafting, Skin

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.

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.

Interventions

DRUGTisseel Fibrin Sealant

Sponsors

Shriners Hospitals for Children
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frame
outcome and cosmetic appearance at routine intervals up to 24 months
initial graft fixation
percent graft take at 1 week
initial wound hemostasis
initial donor site hemostasis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026