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

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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)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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