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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 is a Phase 1 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 40 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00161759
The ClinicalTrials.gov registry entry for NCT00161759 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 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 1 intervention - of which Sheet skin grafts affixed with Fibrin Sealant (lyophilized) with 4 IU/mL Thrombin is the first listed.
NCT00161759 reports 0 study locations.
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.
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