Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds

Completed

Conditions studied: Complex Lower Extremity Soft Tissue Reconstruction

In brief

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.

Key facts

Study ID

NCT01947387

Run by

Integra LifeSciences Corporation

People needed

320

Starts

2013-08-01

Expected to finish

2015-02-01

Last updated by the study team

2016-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diabetic (I or II) male or female, age greater than 18 years
• 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.

You may not qualify if…

• Age less than 18 years

Where it is running

• 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

Full record on ClinicalTrials.gov

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