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

Integra LifeSciences

Status: Completed

Conditions: Complex Lower Extremity Soft Tissue Reconstruction

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01947387

Integra 11-2011

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 9 patient groups

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)