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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: Completed study, sponsored by Integra LifeSciences Corporation.
NCT01947387 is a clinical trial that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 320 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A dermoinductive agent is a product that is said to promote rapid wound healing.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-02 |
What the finished NCT01947387 record still lists
NCT01947387 is an observational study that tracks outcomes without assigning an intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01947387 does not publish any study locations in the registry export this page uses.
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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