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

NCT03773575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2026-03-25

Study results available
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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.

Conditions

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

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Acelity

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Paul DiMuzio, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2024-07-15
Completion
2024-08-15
FDA Device
Yes

Countries

  • United States
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03773575 on ClinicalTrials.gov