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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

August 30, 2006
March 6, 2009
August 2006
June 2007   (final data collection date for primary outcome measure)
The incidence and severity of adverse events [ Time Frame: Up to day 29 ] [ Designated as safety issue: Yes ]
The incidence and severity of adverse events
Complete list of historical versions of study NCT00371215 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The incidence and grade of clinical laboratory abnormalities
  • The incidence of anti-rhThrombin product antibodies
  • The incidence of hemostasis
  • The percentage of graft take
  • The incidence of re-grafting
Not Provided
Not Provided
 
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Surgical Hemostasis
Biological: rThrombin
1000 U/mL applied topically
Experimental: 1
rThrombin
Intervention: Biological: rThrombin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
2 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00371215
499E02
Yes
Allan Alexander, MD, ZymoGenetics, Inc.
ZymoGenetics
Not Provided
Study Director: Allan Alexander, MD ZymoGenetics
ZymoGenetics
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP