NCT03773575

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 12, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

December 10, 2018

Results QC Date

January 26, 2026

Last Update Submit

March 23, 2026

Conditions

AmputationAmputation; Postoperative, SequelaeWound DehiscenceSeromaWound Infection, SurgicalLymph Leakage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Length of Stay (LOS)

    30 days post procedure

  • 30-day Return to Operating Room (ROR)

    30 days post procedure

  • 30-day Hospital Readmissions

    30 days post procedure

  • Incidence of Skin Dehiscence

    30 days post procedure

  • Incidence of Fascial Dehiscence

    30 Days

  • +5 more secondary outcomes

Study Arms (2)

Prevena

EXPERIMENTAL

PREVENA™ PEEL \& PLACE™ Dressing Kit

Device: PREVENA™ PEEL & PLACE™ Dressing Kit

Standard Care

NO INTERVENTION

sterile gauze dressing supplemented with an Ace wrap

Interventions

PREVENA™ PEEL & PLACE™ Dressing KitDEVICE

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).

Prevena

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Minors under 18 years
  • Women who are pregnant or breastfeeding
  • Patients having BOTH legs amputated
  • Patients with sensitivity to silver
  • Unwilling or unable to provide informed consent
  • Inability to comply with planned study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Thomas Jefferson University/Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Gemelli Hospital

Roma, RM, 8, 00168, Italy

Location

Related Publications (8)

  • Hasanadka R, McLafferty RB, Moore CJ, Hood DB, Ramsey DE, Hodgson KJ. Predictors of wound complications following major amputation for critical limb ischemia. J Vasc Surg. 2011 Nov;54(5):1374-82. doi: 10.1016/j.jvs.2011.04.048. Epub 2011 Aug 15.

    PMID: 21840153BACKGROUND

  • Belmont PJ Jr, Davey S, Orr JD, Ochoa LM, Bader JO, Schoenfeld AJ. Risk factors for 30-day postoperative complications and mortality after below-knee amputation: a study of 2,911 patients from the national surgical quality improvement program. J Am Coll Surg. 2011 Sep;213(3):370-8. doi: 10.1016/j.jamcollsurg.2011.05.019. Epub 2011 Jul 1.

    PMID: 21723151BACKGROUND

  • Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.

    PMID: 21804414BACKGROUND

  • Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15.

    PMID: 21761149BACKGROUND

  • Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.

    PMID: 23111014BACKGROUND

  • Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084.

    PMID: 26994715BACKGROUND

  • Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17.

    PMID: 30126781BACKGROUND

  • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.

    PMID: 497341BACKGROUND

Related Links

MeSH Terms

Conditions

SeromaSurgical Wound Infection

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsWound InfectionInfectionsPostoperative Complications

Results Point of Contact

Title
Paul DiMuzio, MD
Organization
Thomas Jefferson University
paul.dimuzio@jefferson.edu
215-955-8304

Study Officials

  • Paul DiMuzio, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 12, 2018

Study Start

January 15, 2019

Primary Completion

July 15, 2024

Study Completion

August 15, 2024

Last Updated

March 25, 2026

Results First Posted

February 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)IT(1)