Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181974
Status:
COMPLETED
Last Update Posted:
2012-10-24
First Post:
2005-09-14
Brief Title:
Efficacy of a Fibrin Sealant in Burn Surgery
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Efficacy of a Fibrin Sealant in Burn Surgery
Status:
COMPLETED
Status Verified Date:
2012-10
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 determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation
Detailed Description:
Burn patients require extensive split-thickness skin grafting operations These operations necessitate excision of burn wounds and the procurement of autografts Both of these result in bleeding open wounds Fibrin sealants may be of benefit in three aspects of burn surgery
1 as a hemostatic agent on excised burns
2 as a hemostatic agent on donor sites and
3 as a method of fixation of skin grafts to wounds
Skin grafts are routinely secured with surgical staples Patients with large burns will commonly have hundreds even thousands of staples used during the course of their care Problems associated with the use of surgical staples include
1 discomfort upon removal and
2 staples become deeply embedded in the tissue
If effective in securing skin grafts fibrin glue would directly benefit burn patients by decreasing the number of staples required and thereby decreasing the number of retained staples Fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma that is virally inactivated by a two-stage heating process
Subjects will serve as their own control They will have an area of their wound treated with the fibrin sealant and another area treated with the standard of care Both areas will be compared for hemostasis skin graft fixation wound healing and cosmetic outcome
1 as a hemostatic agent on excised burns
2 as a hemostatic agent on donor sites and
3 as a method of fixation of skin grafts to wounds
Skin grafts are routinely secured with surgical staples Patients with large burns will commonly have hundreds even thousands of staples used during the course of their care Problems associated with the use of surgical staples include
1 discomfort upon removal and
2 staples become deeply embedded in the tissue
If effective in securing skin grafts fibrin glue would directly benefit burn patients by decreasing the number of staples required and thereby decreasing the number of retained staples Fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma that is virally inactivated by a two-stage heating process
Subjects will serve as their own control They will have an area of their wound treated with the fibrin sealant and another area treated with the standard of care Both areas will be compared for hemostasis skin graft fixation wound healing and cosmetic outcome
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