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

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation; Seroma; Wound Infection, Surgical; Wound Dehiscence; Lymph Leakage; Amputation; Postoperative, Sequelae
• Intervention / Treatment: Device: PREVENA™ PEEL & PLACE™ Dressing Kit

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 Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa McCarey; Phone Number: 215-503-7417; Email: melissa.mccarey@jefferson.edu

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 8, 00168
      • Recruiting
      • Gemelli Hospital
      • Contact: Federico Biscetti; Email: federico.biscetti@policlinicogemelli.it
      • Principal Investigator: Federico Biscetti, MD
• United States
  • New York
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Westchester Medical Center
      • Principal Investigator: Jeontaik Kwon, MD
      • Contact: Christopher Hall; Email: Christopher.Hall2@wmchealth.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University/Hospital
      • Contact: Melissa McCarey; Phone Number: 215-503-7417; Email: melissa.mccarey@jefferson.edu
      • Principal Investigator: Paul DiMuzio, MD
      • Sub-Investigator: Dawn Salvatore, MD
      • Sub-Investigator: Babak Abai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevena; PREVENA™ PEEL & PLACE™ Dressing Kit	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).
No Intervention: Standard Care; sterile gauze dressing supplemented with an Ace wrap

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day hospitalization costs	Index hospitalization costs as well as all readmission days within 30d related to any wound complication	admission to discharge; 30 days post procedure
30-day hospital variable costs	Variable costs (not charges) for each admission obtained from hospital administration	admission to discharge; 30 days post procedure

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Acelity
• Investigators: Principal Investigator: Paul DiMuzio, MD, Thomas Jefferson University

Publications and helpful links

General Publications

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

Helpful Links

• National Healthcare Safety Network definition of Surgical Site Infection (SSI) Event

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Anticipated): July 15, 2024
• Study Completion (Anticipated): August 15, 2024

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: 18P.577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes