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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773575
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Acelity
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Amputation Amputation; Postoperative, Sequelae Wound Dehiscence Seroma Wound Infection, Surgical Lymph Leakage Device: PREVENA™ PEEL & PLACE™ Dressing Kit Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Overall rate of wound complications [ Time Frame: 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 :
  1. Length of stay (LOS) [ Time Frame: 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

  2. 30-day Return to Operating Room (ROR) [ Time Frame: 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

  3. 30-day hospital readmissions [ Time Frame: 30 days post procedure ]
    Rehospitalization for wound complication within 30 days

  4. Incidence rates of wound complications [ Time Frame: 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


Other Outcome Measures:
  1. 30-day hospitalization costs [ Time Frame: admission to discharge; 30 days post procedure ]
    Index hospitalization costs as well as all readmission days within 30d related to any wound complication

  2. 30-day hospital variable costs [ Time Frame: admission to discharge; 30 days post procedure ]
    Variable costs (not charges) for each admission obtained from hospital administration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773575


Contacts
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Contact: Laura Anatale-Tardiff 2155034280 laura.anatale.tardiff@jefferson.edu

Locations
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United States, New York
Upstate University Hospital Not yet recruiting
Syracuse, New York, United States, 13210
Contact: Michael Costanza, MD       costanzm@upstate.edu   
Principal Investigator: Michael Costanza, MD         
Westchester Medical Center Not yet recruiting
Valhalla, New York, United States, 10595
Contact: Geena George       geena.george@wmchealth.org   
Principal Investigator: Jeontaik Kwon, MD         
United States, Pennsylvania
Abington Hospital Not yet recruiting
Abington, Pennsylvania, United States, 19001
Contact: Kimberly Alfaro, CRNP    215-887-5934    kalfaro@abingtonhealth.org   
Principal Investigator: Danielle Pineda, MD         
Sub-Investigator: Robert Jubelirer, MD         
Sub-Investigator: Richard Parsons, MD         
Sub-Investigator: Theodore Sullivan, MD         
Thomas Jefferson University/Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Laura Anatale-Tardiff    215-503-4280    laura.anatale.tardiff@jefferson.edu   
Principal Investigator: Paul DiMuzio, MD         
Sub-Investigator: Dawn Salvatore, MD         
Sub-Investigator: Babak Abai, MD         
Italy
Gemelli Hospital Not yet recruiting
Roma, RM, Italy, 8, 00168
Contact: Alessandra Falsetti       alessandra.falsetti@policlinicogemelli.it   
Principal Investigator: Raffaele Landolfi, MD         
Sub-Investigator: Ignacio Marino, MD         
Sponsors and Collaborators
Thomas Jefferson University
Acelity
Investigators
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Principal Investigator: Paul DiMuzio, MD Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Thomas Jefferson University:
Additional Information:
Publications:

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03773575    
Other Study ID Numbers: 18P.577
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Wounds and Injuries
Infection
Pathologic Processes
Postoperative Complications