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NCT00157131 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT00157131 is a Phase 3 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 150 participants.
The verdict
NCT00157131, a Phase 3 study, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study 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.
Interventions
- OTHER Staples
- BIOLOGICAL Fibrin Sealant, ARTISS 4IU/ml VH SD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-06 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00157131
The ClinicalTrials.gov registry entry for NCT00157131 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxter Healthcare Corporation, which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Staples is the first listed.
NCT00157131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00157131 about?
NCT00157131 is a clinical study titled "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". 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.
What is the current status of trial NCT00157131?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2004-06. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00157131?
The interventions under investigation include: Staples (OTHER), Fibrin Sealant, ARTISS 4IU/ml VH SD (BIOLOGICAL).
Who is sponsoring clinical trial NCT00157131?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
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