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NCT00161759 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds
A Phase 1 study, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00161759: Completed Phase 1 study, sponsored by Baxter Healthcare Corporation.
NCT00161759 is a Phase 1 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00161759, a Phase 1 study, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites.
Interventions
- DRUG Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2002-03 |
| Est. Completion | 2004-01 |
| Phase | Phase 1 |
What the finished NCT00161759 record still lists
NCT00161759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin is the first listed.
NCT00161759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00161759 about?
NCT00161759 is a clinical study titled "Safety and Efficacy Study of Fibrin Sealant (FS 4IU) for Skin Graft Fixation and Wound Healing in Subjects With Burn Wounds". The purpose of this study is to assess if Fibrin Sealant 4IU is as safe and efficacious as staples (the current standard of care) to achieve fixation of skin grafts and wound healing in subjects with burn wounds. Each subject receives staples as well as FS 4IU on comparable treatment sites.
What is the current status of trial NCT00161759?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2002-03. Estimated completion is 2004-01.
What interventions are being tested in trial NCT00161759?
The interventions under investigation include: Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin (DRUG).
Who is sponsoring clinical trial NCT00161759?
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 NCT00161759's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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