Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, S… (NCT00157131) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients
United States150 participantsStarted 2004-06
Plain-language summary
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.
Who can participate
Age range65 Years
SexALL
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Inclusion Criteria:
* Subjects or their legal representatives, who have read, understood and signed a written informed consent.
* Subjects of either sex.
* Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission.
* Subjects who are \<= 65 years of age including pediatric subjects of all ages.
* Subjects with total burn wounds measuring \<= 40% TBSA.
* Subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% TBSA or two comparable, bilateral wounds each measuring between 1% and 4% TBSA.
* Wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000" - 16/1000"
* Subjects who are able, and willing to comply with the procedures required by the protocol.
Exclusion Criteria:
* Subjects with electrical burns.
* Subjects with chemical burns
* Digits and genitalia are excluded as test sites.
* Subjects with infection at test area/test sites.
* Subjects with test sites previously randomized and treated in this study.
* Subjects with venous or arterial vascular disorder that directly affects a designated test area/test site.
* Subjects with pre-existing hemolytic anemia
* Subjects with diabetes mellitus.
* Subjects with documented history of pathologically or pharmacologically induced immune deficiency.
* Subjects judged to be chronically malnourished.
* Subjects that are judged to have significant pulmonary compromise.
* Subjects receiving systemic corticosteroids within…
What they're measuring
1
Complete wound closure by Day 28 after treatment with either FS 4IU VH S/D or staples as determined by a blinded independent review of the Day 28 photographs
Timeframe: 28 days after treatment
2
Adverse experiences (AEs) deemed possibly or probably related to treatment with FS 4IU VH S/D