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

Completed

• Conditions: Complex Lower Extremity Soft Tissue Reconstruction

• Registration Number: NCT01947387
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2014-09
• Study Completion: 2015-02
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• 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.

Exclusion Criteria

• Age less than 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	5 year period	A dermoinductive agent is a product that is said to promote rapid wound healing.

Secondary Outcome Measures

Name	Time	Method
Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy.	5 year period

Trial Locations

Locations (4)

Northwestern University Feinberg School of Medicine Division of Plastic Surgery; 🇺🇸 Chicago, Illinois, United States

Georgetown University Hospital Wound Healing Center; 🇺🇸 Washington, District of Columbia, United States

Brigham and Women's Hospital, Inc; 🇺🇸 Boston, Massachusetts, United States

University of Texas Southwestern Medical Ceter; 🇺🇸 Dallas, Texas, United States