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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: Completed Phase 3 study, sponsored by Baxter Healthcare Corporation.
NCT00157131 is a Phase 3 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00157131 record still lists
NCT00157131 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Staples is the first listed.
NCT00157131 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00157131's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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