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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2024-08-15

Brief Summary

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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.

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Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Prevena

PREVENA™ PEEL \& PLACE™ Dressing Kit

Group Type EXPERIMENTAL

PREVENA™ PEEL & PLACE™ Dressing Kit

Intervention Type DEVICE

In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT).

Standard Care

sterile gauze dressing supplemented with an Ace wrap

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PREVENA™ PEEL & PLACE™ Dressing Kit

In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No