Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

This study has been completed.
Sponsor:
Information provided by:
ZymoGenetics
ClinicalTrials.gov Identifier:
NCT00371215
First received: August 30, 2006
Last updated: March 6, 2009
Last verified: March 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The incidence and grade of clinical laboratory abnormalities [ Time Frame: Up to day 29 ] [ Designated as safety issue: Yes ]
  • The incidence of anti-rThrombin product antibodies [ Time Frame: Up to day 29 ] [ Designated as safety issue: Yes ]
  • The incidence of hemostasis [ Time Frame: Up to 20 minutes ] [ Designated as safety issue: Yes ]
  • The percentage of graft take [ Time Frame: Up to day 29 ] [ Designated as safety issue: No ]
  • The incidence of re-grafting [ Time Frame: Up to day 29 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Allan Alexander, MD, ZymoGenetics, Inc.
ClinicalTrials.gov Identifier: NCT00371215     History of Changes
Other Study ID Numbers: 499E02
Study First Received: August 30, 2006
Last Updated: March 6, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014