NCT Number: NCT01947387
Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds
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.
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Georgetown University Hospital Wound Healing Center, Washington D.C., District of Columbia, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Time frame: 5 year period
A dermoinductive agent is a product that is said to promote rapid wound healing.
Secondary outcomes
-
Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy.
Time frame: 5 year period
Other outcomes
-
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
Time frame: 5 years
-
Time to complete re-epithelization (as deemed by the surgeon) after Integra application or NPWT
Time frame: 5 years
Sponsors and collaborators
Lead sponsor
Integra LifeSciences Corporation
Industry
Collaborators
- Georgetown University
Registry information
Official study 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
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- Sep 20, 2013
- Registry last updated
- Dec 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.