Clinical trial NCT01947387: Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Lower Extremity Soft Tissue Reconstruction
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Georgetown University
First posted: 2013-09-20
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 5 year period
Secondary outcomes:
measure: Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy.
timeFrame: 5 year period
Other outcomes:
measure: 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
timeFrame: 5 years
measure: Time to complete re-epithelization (as deemed by the surgeon) after Integra application or NPWT
timeFrame: 5 years
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital Wound Healing Center
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine Division of Plastic Surgery
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital, Inc
state: Massachusetts
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Ceter
state: Texas
Study officials:
References: