Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

March 6, 2009 updated by: ZymoGenetics

A Phase 2 Study of Recombinant Human Thrombin (rThrombin) Administered Using a Spray Applicator in Subjects Undergoing Autologous Skin Grafting Following Burn or Traumatic Skin Injury

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Richard M. Fairbanks Burn Center, Wishard Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
rThrombin
Biological: rThrombin
1000 U/mL applied topically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence and severity of adverse events
Time Frame: Up to day 29
Up to day 29

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence and grade of clinical laboratory abnormalities
Time Frame: Up to day 29
Up to day 29
The incidence of anti-rThrombin product antibodies
Time Frame: Up to day 29
Up to day 29
The incidence of hemostasis
Time Frame: Up to 20 minutes
Up to 20 minutes
The percentage of graft take
Time Frame: Up to day 29
Up to day 29
The incidence of re-grafting
Time Frame: Up to day 29
Up to day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZymoGenetics

Investigators

  • Study Director: Allan Alexander, MD, ZymoGenetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

September 1, 2006

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 499E02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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