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AmputationPREVENA-AMPNCT03773575

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

A study testing PREVENA™ PEEL & PLACE™ Dressing Kit in people with Amputation and Amputation; Postoperative, Sequelae, run by Thomas Jefferson University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PREVENA™ PEEL & PLACE™ Dressing Kit
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
3 sitesin 2 countries
Study dates
15 Jan 2019to 15 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Thomas Jefferson University/Hospital

    Philadelphia, Pennsylvania, 19107

  • Westchester Medical Center

    Valhalla, New York, 10595

Other trials in United States

Italy1 site

  • Gemelli Hospital

    Roma, RM, 8, 00168

Other trials in Italy

About this study

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.

Read the 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

Being tested
PREVENA™ PEEL & PLACE™ Dressing Kit
Medical subject headings
Seroma, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT03773575
Study groupRoleWhat they receive
PrevenaExperimentalPREVENA™ PEEL \& PLACE™ Dressing Kit
Receives: Device: PREVENA™ PEEL & PLACE™ Dressing Kit
Standard CareNo interventionsterile gauze dressing supplemented with an Ace wrap

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days post procedure

Secondary outcomes (10)

  1. 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

    Measured: 30 days post procedure

  2. 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

    Measured: 30 days post procedure

  3. 30-day Hospital Readmissions

    Rehospitalization for wound complication within 30 days

    Measured: 30 days post procedure

  4. Incidence of Skin Dehiscence

    Individual rates of the incidence of skin dehiscence

    Measured: 30 days post procedure

  5. Incidence of Fascial Dehiscence

    Individual incidence rate of fascial dehiscence

    Measured: 30 Days

  6. Incidence of Superficial Skin Infection

    Individual incidence of superficial skin infection

    Measured: 30 days

  7. Incidence of Deep Skin Infection

    Individual incidence of deep skin infection

    Measured: 30 days

  8. Incidence of Seroma

    Individual incidence of seroma

    Measured: 30 Days

  9. Incidence of Hematoma

    Individual Incidence of Hematoma

    Measured: 30 days

  10. Incidence of Necrosis

    Individual incidence of Necrosis

    Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2018
  2. Study start15 Jan 2019
  3. Primary completion15 Jul 2024
  4. Study completion15 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03773575
Sponsor's protocol ID
18P.577
Acronym
PREVENA-AMP
Status last verified
Mar 2026
First submitted
10 Dec 2018
Last updated
25 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 21840153

  • 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.

    PubMed 21723151

  • 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.

    PubMed 21804414

  • 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.

    PubMed 21761149

  • 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.

    PubMed 23111014

  • 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.

    PubMed 26994715

  • 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.

    PubMed 30126781

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

    PubMed 497341

Questions about this trial

What is this clinical trial studying?

A study testing PREVENA™ PEEL & PLACE™ Dressing Kit in people with Amputation and Amputation; Postoperative, Sequelae, run by Thomas Jefferson University at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Rate of Wound Complications (time frame: 30 days post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03773575, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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