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Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

NCT ID: NCT00371215

Last Updated: 2009-03-09

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

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Surgical Hemostasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

rThrombin

Group Type EXPERIMENTAL

rThrombin

Intervention Type BIOLOGICAL

1000 U/mL applied topically

Interventions

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rThrombin

1000 U/mL applied topically

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZymoGenetics

INDUSTRY

Sponsor Role lead

Responsible Party

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ZymoGenetics, Inc.

Principal Investigators

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Allan Alexander, MD

Role: STUDY_DIRECTOR

ZymoGenetics

Locations

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Richard M. Fairbanks Burn Center, Wishard Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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499E02

Identifier Type: -

Identifier Source: org_study_id

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