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

Not Applicable

Recruiting

• Conditions: Amputation; Wound Dehiscence; Seroma; Amputation; Postoperative, Sequelae; Wound Infection, Surgical; Lymph Leakage
• Interventions: Device: PREVENA™ PEEL & PLACE™ Dressing Kit

• Registration Number: NCT03773575
• Lead Sponsor: Thomas Jefferson University

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

Study Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Study Start: 2019-01-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03
• Primary Completion: 2024-07-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prevena	PREVENA™ PEEL & PLACE™ Dressing Kit	PREVENA™ PEEL \& PLACE™ Dressing Kit

Primary Outcome Measures

Name	Time	Method
Overall rate of wound complications	30 days post procedure	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

Secondary Outcome Measures

Name	Time	Method
30-day hospital readmissions	30 days post procedure	Rehospitalization for wound complication within 30 days
Length of stay (LOS)	30 days post procedure	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-day Return to Operating Room (ROR)	30 days post procedure	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
Incidence rates of wound complications	30 days post procedure	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

Trial Locations

Locations (3)

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

Thomas Jefferson University/Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Gemelli Hospital; 🇮🇹 Roma, RM, Italy