An observational study in Complex Lower Extremity Soft Tissue Reconstruction, sponsored by Integra LifeSciences Corporation. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-02.
Sponsored by Integra LifeSciences Corporation · Observational
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.
Integra LifeSciences Corporation is the lead sponsor of 82 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: 5 year period
Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy.
Time frame: 5 year period
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
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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