Clinical trial NCT03773575: Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
Official title: Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation
Amputation; Postoperative, Sequelae
Wound Dehiscence
Seroma
Wound Infection, Surgical
Lymph Leakage
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Acelity
First posted: 2018-12-12
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Overall rate of wound complications
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Length of stay (LOS)
timeFrame: 30 days post procedure
measure: 30-day Return to Operating Room (ROR)
timeFrame: 30 days post procedure
measure: 30-day hospital readmissions
timeFrame: 30 days post procedure
measure: Incidence rates of wound complications
timeFrame: 30 days post procedure
Other outcomes:
measure: 30-day hospitalization costs
timeFrame: admission to discharge; 30 days post procedure
measure: 30-day hospital variable costs
timeFrame: admission to discharge; 30 days post procedure
Locations:
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University/Hospital
state: Pennsylvania
city: Roma
country: Italy
facility: Gemelli Hospital
state: RM
Study officials:
affiliation: Thomas Jefferson University
name: Paul DiMuzio, MD
role: PRINCIPAL_INVESTIGATOR
References:
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