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Sheet skin grafts affixed with Fibrin Sealant with/mL Thrombin

Phase 1

Burns | Small molecule | Dermatology |Baxter International Inc.|Last Updated: Oct 20, 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Sheet skin grafts affixed with Fibrin Sealant with/mL Thrombin · 1 trial · 1 indication

Phase 1 1
NCT00161759Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn WoundsBurns
COMPLETED40 Analytics
PHASE1COMPLETED
Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds
Burns
NCT0016175940
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL ThrombinDRUG -
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Eligibility Criteria

Age Range6 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to screening activities * Male or female age \>= 6 and \<= 65 years of age * Total burn wounds measuring \<= 40% TBSA to include a deep partial thickness/full thi...

Countries:United States
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