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Completed

NCT Number: NCT00181974

Efficacy of a Fibrin Sealant in Burn Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Burns Hospital

Boston, Massachusetts, 02114, United States

About this study

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:

  • as a hemostatic agent on excised burns,
  • as a hemostatic agent on donor sites, and
  • 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:

  • discomfort upon removal and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tisseel Fibrin Sealant

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Shriners Hospitals for Children

Registry information

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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