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Efficacy of a Fibrin Sealant in Burn Surgery

NCT ID: NCT00181974

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Burns

Keywords

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burns hemostasis skin graft Surgical Hemostasis Grafting, Skin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tisseel Fibrin Sealant

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Robert L. Sheridan

Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert L Sheridan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shriners Burns Hospital

Locations

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Shriners Burns Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Not sponsored

Identifier Type: -

Identifier Source: org_study_id