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

Thomas Jefferson University

Status: Completed

Conditions: Wound Dehiscence; Seroma; Wound Infection, Surgical; Amputation; Amputation; Postoperative, Sequelae; Lymph Leakage

Treatments: Device: PREVENA™ PEEL & PLACE™ Dressing Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT03773575

18P.577

Details and patient eligibility

About

This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.

Full description

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

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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272 participants in 2 patient groups

Prevena

Experimental group

Description:

PREVENA™ PEEL \& PLACE™ Dressing Kit

Treatment:

Device: PREVENA™ PEEL & PLACE™ Dressing Kit

Standard Care

No Intervention group

Description:

sterile gauze dressing supplemented with an Ace wrap