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

Study Overview
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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.

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

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

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

Intervention / Treatment
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* Device: PREVENA™ PEEL & PLACE™ Dressing Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults 18 years or older Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations) Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations) Informed Consent signed by patient Exclusion Criteria: Minors under 18 years Women who are pregnant or breastfeeding Patients undergoing emergent or guillotine amputation Patients having BOTH legs amputated Patients with sensitivity to silver Unwilling or unable to provide informed consent Inability to comply with planned study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena<br>PREVENA™ PEEL & PLACE™ Dressing Kit | Device: PREVENA™ PEEL & PLACE™ Dressing Kit<br>* 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).<br>|
| No Intervention: Standard Care<br>sterile gauze dressing supplemented with an Ace wrap | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall rate of wound complications | Presence of any of the following post-procedure: Dehiscence (skin or fascia) Seroma Lymph leak Infection (superficial or deep, using CDC Surgical Site Infection criteria) Hematoma Ischemia Necrosis | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (LOS) | index LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complication | 30 days post procedure | 
| 30-day Return to Operating Room (ROR) | Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation | 30 days post procedure | 
| 30-day hospital readmissions | Rehospitalization for wound complication within 30 days | 30 days post procedure | 
| Incidence rates of wound complications | Individual rates of the incidence of each of the following: Dehiscence (skin or fascia) Seroma Lymph leak Infection (superficial or deep, using CDC Surgical Site Infection criteria) Hematoma Ischemia Necrosis | 30 days post procedure |