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Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371215
First Posted: September 1, 2006
Last Update Posted: March 9, 2009
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.
Information provided by:
ZymoGenetics
  Purpose
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

Condition Intervention Phase
Surgical Hemostasis Biological: rThrombin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ZymoGenetics:

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

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

Enrollment: 72
Study Start Date: August 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
rThrombin
Biological: rThrombin
1000 U/mL applied topically

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00371215


Locations
United States, Indiana
Richard M. Fairbanks Burn Center, Wishard Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
ZymoGenetics
Investigators
Study Director: Allan Alexander, MD ZymoGenetics
  More Information

Responsible Party: Allan Alexander, MD, ZymoGenetics, Inc.
ClinicalTrials.gov Identifier: NCT00371215     History of Changes
Other Study ID Numbers: 499E02
First Submitted: August 30, 2006
First Posted: September 1, 2006
Last Update Posted: March 9, 2009
Last Verified: March 2009

Keywords provided by ZymoGenetics:
hemostasis
grafting, skin
hemostatics
phase 2

Additional relevant MeSH terms:
Thrombin
Hemostatics
Coagulants