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.
Study Type
OBSERVATIONAL
Enrollment
320
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
Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy.
A dermoinductive agent is a product that is said to promote rapid wound healing.
Time frame: 5 year period
Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy.
Time frame: 5 year period
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