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

Incisional negative pressure wound therapy is an approved device used for wound healing of
closed surgical incisions. This research is being done because incisional negative pressure
wound therapy is a new application of negative pressure wound therapy that is applied over a
closed incision area instead of an open wound. Negative pressure wound therapy is commonly
used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and
a battery-powered device that places negative pressure on the wound. Currently, there are no
trials utilizing incisional negative pressure wound therapy of closed wounds after below knee
amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above
Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure
wound therapy and standard dressings in patients.

Inclusion Criteria:

1. Must be at least 18 years or older to participate.

2. Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee
Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).

3. Has at least one artery that feeds the closure site.

4. Able to comply with clinical trial procedures and schedule.

Exclusion Criteria:

1. Patients not receiving an amputation.

2. The investigator/provider determines that the patient has an indication against
incisional negative pressure wound therapy that would prevent them from participating.

3. Surgical incision that is not completely closed.