UnknownNot Applicable

Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations

United States112 participantsStarted 2017-11-01

Plain-language summary

The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Must be at least 18 years or older to participate.
✓. Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).
✓. Has at least one artery that feeds the closure site.
✓. Able to comply with clinical trial procedures and schedule.

Exclusion criteria

✕. Patients not receiving an amputation.
✕. The investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating.
✕. Surgical incision that is not completely closed.

What they're measuring

Proportion of postoperative incision complications between the 2 arms

Timeframe: 95 days

Trial details

NCT IDNCT03250442

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09

Contact for this trial

Christopher Attinger, MD

202-444-8780 christopher.attinger@medstar.net

View on ClinicalTrials.gov More Surgical Wound trials