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Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371215
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : March 9, 2009
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Brief Summary:
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

Condition or disease Intervention/treatment Phase
Surgical Hemostasis Biological: rThrombin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Biological: rThrombin
1000 U/mL applied topically

Primary Outcome Measures :
  1. The incidence and severity of adverse events [ Time Frame: Up to day 29 ]

Secondary Outcome Measures :
  1. The incidence and grade of clinical laboratory abnormalities [ Time Frame: Up to day 29 ]
  2. The incidence of anti-rThrombin product antibodies [ Time Frame: Up to day 29 ]
  3. The incidence of hemostasis [ Time Frame: Up to 20 minutes ]
  4. The percentage of graft take [ Time Frame: Up to day 29 ]
  5. The incidence of re-grafting [ Time Frame: Up to day 29 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371215

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United States, Indiana
Richard M. Fairbanks Burn Center, Wishard Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
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Study Director: Allan Alexander, MD ZymoGenetics
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Responsible Party: Allan Alexander, MD, ZymoGenetics, Inc. Identifier: NCT00371215    
Other Study ID Numbers: 499E02
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009
Keywords provided by ZymoGenetics:
grafting, skin
phase 2