Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

ZymoGenetics

Status and phase: Completed; Phase 2

Conditions: Surgical Hemostasis

Treatments: Biological: rThrombin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00371215

499E02

Details and patient eligibility

About

The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

Full description

This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.

Enrollment: 72 patients

Sex: All

Ages: 2 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury

Exclusion criteria

• Known antibodies or hypersensitivity to thrombin or other coagulation factors

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

1

Experimental group

Description:

rThrombin

Treatment:

Biological: rThrombin