Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications

This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to
evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL & PLACE™
Dressing Kit) on incidence of post-operative wound complications in patients undergoing
above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately
five (5) participating sites will be randomized to receive either the Prevena dressing or a
standard care dressing. The incision will be assessed for complications at post-op day 5 or
day 6 and at approximately 30 days after discharge. The primary outcome of this study is
reported wound complications, including dehiscence (opening of the incision), seroma, lymph
leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood
supply), and necrosis (tissue death) A major complication is defined as any wound
complication requiring intravenous or oral antibiotics, reoperation and/or hospital
readmission. All data (demographics, medical history, and clinical outcomes) will be
collected via medical record review

Inclusion Criteria:

1. Male or female adults 18 years or older

2. Patients undergoing above-knee amputation (includes the revision of emergency
guillotine amputations)

3. Patients undergoing below-knee amputation (includes the revision of emergency
guillotine amputations)

4. Informed Consent signed by patient

Exclusion Criteria:

1. Minors under 18 years

2. Women who are pregnant or breastfeeding

3. Patients undergoing emergent or guillotine amputation

4. Patients having BOTH legs amputated

5. Patients with sensitivity to silver

6. Unwilling or unable to provide informed consent

7. Inability to comply with planned study procedures