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

A Retrospective, Multi-Center Study Evaluating the Outcomes for Integra® Skin Sheet Bilayer or Single Layer Products Used in Complex Lower Extremity Soft Tissue Reconstruction

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 Overview

• Status: Completed
• Conditions: Complex Lower Extremity Soft Tissue Reconstruction

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital Wound Healing Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine Division of Plastic Surgery
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital, Inc
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Ceter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who received Integra, free flap, local tissue flap, or negative pressure wound therapy over a 5-year period. The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort
Integra
Integra + NPWT (short-inpatient use only)
Integra + NPWT (long-all other durations)
Integra + STSG
Integra + Dermoinductive Agent
Free Flap
Local Tissue Flap
NPWT
NPWT then Integra (on same admission)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 year period

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Time to wound bed preparation for receipt of a split thickness skin graft (STSG) or dermoinductive agent after having received Integra or negative pressure wound therapy	5 years
Time to complete re-epithelization (as deemed by the surgeon) after Integra application or NPWT	5 years

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Collaborators: Georgetown University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: August 12, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Integra 11-2011