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NCT01947387 · ClinicalTrials.gov registry record
Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds
A clinical trial, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- 320
- Enrollment target
NCT01947387 is a clinical trial that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 320 participants.
The verdict
NCT01947387 has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- 320 participants
- Enrollment target
Study Summary
This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Participating sites will collect information for all patients who received Integra, free flap, local tissue flap, or negative pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index procedure, with index procedure being defined as the application of Integra, free flap, local tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for inclusion.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01947387
The ClinicalTrials.gov registry entry for NCT01947387 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01947387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01947387 about?
NCT01947387 is a clinical study titled "Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds". This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Participating sites will collect information for all patients who ...
What is the current status of trial NCT01947387?
This trial is currently completed. The enrollment target is 320 participants. The study started on 2013-08. Estimated completion is 2015-02.
Who is sponsoring clinical trial NCT01947387?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
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