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

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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

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • 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
  • 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
  • 30-day hospital readmissions [ Time Frame: 30 days post procedure ]
    Rehospitalization for wound complication within 30 days
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2018)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
Official Title  ICMJE Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Amputation
  • Amputation; Postoperative, Sequelae
  • Wound Dehiscence
  • Seroma
  • Wound Infection, Surgical
  • Lymph Leakage
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Experimental: Prevena
    PREVENA™ PEEL & PLACE™ Dressing Kit
    Intervention: Device: PREVENA™ PEEL & PLACE™ Dressing Kit
  • No Intervention: Standard Care
    sterile gauze dressing supplemented with an Ace wrap
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Anatale-Tardiff 2155034280 laura.anatale.tardiff@jefferson.edu
Listed Location Countries  ICMJE Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773575
Other Study ID Numbers  ICMJE 18P.577
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Acelity
Investigators  ICMJE
Principal Investigator: Paul DiMuzio, MD Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP