Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds
NCT ID: NCT01947387
Last Updated: 2016-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
320 participants
OBSERVATIONAL
2013-08-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RETROSPECTIVE
Study Groups
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Integra
No interventions assigned to this group
Integra + NPWT (short-inpatient use only)
No interventions assigned to this group
Integra + NPWT (long-all other durations)
No interventions assigned to this group
Integra + STSG
No interventions assigned to this group
Integra + Dermoinductive Agent
No interventions assigned to this group
Free Flap
No interventions assigned to this group
Local Tissue Flap
No interventions assigned to this group
NPWT
No interventions assigned to this group
NPWT then Integra (on same admission)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Lower extremity wounds that required operative application of Integra, free flap, local tissue flap, or negative pressure wound therapy. Complex wounds are defined as wounds that involve exposed deep tissue (e.g. bone, tendon, fascia, ligament)
* The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Georgetown University
OTHER
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Locations
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Georgetown University Hospital Wound Healing Center
Washington D.C., District of Columbia, United States
Northwestern University Feinberg School of Medicine Division of Plastic Surgery
Chicago, Illinois, United States
Brigham and Women's Hospital, Inc
Boston, Massachusetts, United States
University of Texas Southwestern Medical Ceter
Dallas, Texas, United States
Countries
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Other Identifiers
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Integra 11-2011
Identifier Type: -
Identifier Source: org_study_id
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