Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371215
Status:
COMPLETED
Last Update Posted:
2009-03-09
First Post:
2006-08-30
Brief Title:
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
Sponsor:
ZymoGenetics
Organization:
ZymoGenetics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None