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Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery

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ClinicalTrials.gov Identifier: NCT02389023
Recruitment Status : Unknown
Verified December 2018 by Daniel Bertges, MD, University of Vermont Medical Center.
Recruitment status was:  Recruiting
First Posted : March 17, 2015
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
KCI USA, Inc.
MaineHealth
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Daniel Bertges, MD, University of Vermont Medical Center

Brief Summary:
The purpose of this study is to evaluate the effectiveness of negative pressure incision management system (Prevena™ Incision Management System (PIMS) or ActiVAC® with the Prevena™ Dressings (Peel and Place™ or Customizable™), KCI) in the prevention of wound complications including surgical site infection (SSI) and non-infectious complications in patients undergoing vascular surgery with groin incisions.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Critical Limb Ischemia Claudication Other: standard gauze dressing Other: Prevena Incision Management system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multicenter, Prospective, Randomized Clinical Trial of a Negative Pressure Incision Management System in High Risk Vascular Surgery Patients
Study Start Date : September 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
standard gauze dressing
a standard post-operative dressing consisting of dry gauze and tape will be placed over the surgical site
Other: standard gauze dressing
Standard gauze dressing with tape will be placed over the surgical incision in the operating room and left on the incision as dictated by standard of care

Prevena Incision Management System
the Prevena™ Incision Management System (PIMS) or ActiVAC® with the PrevenaTM Dressings (Peel and Place™ or Customizable™) will be placed over the surgical site. The Prevena dressing is not considered experimental and has FDA approval for coverage of at risk closed-surgical incisions. The dressing is already in clinical use for vascular surgery bypass operations at the University of Vermont Medical Center.
Other: Prevena Incision Management system
The Prevena dressing system over the closed surgical incision. The dressing consists of a sterile sponge that is placed over the incision followed by a plastic adhesive covering that is used to secure it to the skin forming an air-tight seal. The sponge is then connected by tubing to a vacuum that applies negative pressure to the closed system. This allows fluid to drain from the wound and into a container connected to the dressing.




Primary Outcome Measures :
  1. The primary outcome measure will be a composite endpoint of surgical site infection as per Center for Disease Control definition, major wound non-infectious complications, or graft infection within 30 days of surgery. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. surgical site infection alone at 30 days [ Time Frame: 30 days ]
  2. patient satisfaction as assessed by quality of life survey [ Time Frame: 30 days ]
  3. total costs including outpatient costs to 30 days postoperatively [ Time Frame: 30 days ]
  4. length of index hospital stay and any readmission for wound complications [ Time Frame: 30 days ]
  5. major adverse limb event (MALE) or postoperative death (POD). MALE includes above-ankle amputation of the index limb or major reintervention [ Time Frame: 30 days ]


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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. Age ≥ 18
  2. Patient undergoing vascular surgery that would include a groin incision as a standard part of the operation. Infrainguinal bypass including femoral popliteal/tibial/pedal artery bypass with autogenous or prosthetic conduit.
  3. femoral endarterectomy with or without patch angioplasty involving the common femoral artery and/or profunda and/or proximal superficial artery. The index groin may have undergone prior procedures (may be inflow or outflow for existing grafts), but the patient must have fully healed from the prior operation. May include patients with concomitant proximal and/or distal peripheral vascular intervention. The patch may be autogenous venous or arterial or prosthetic material such as bovine pericardium, dacron or polytetrafluoroethylene (PTFE). Bilateral femoral endarterectomies are eligible for enrollment. The right and left groin incision would be randomized to the same dressing which is consistent with routine clinical practice.
  4. Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion Criteria:

  1. Any groin incision on index leg within 12 weeks prior to treatment initiation.
  2. Infrainguinal bypass without a groin incision including popliteal-tibial or pedal bypass.
  3. Supra inguinal procedures such as open or endovascular abdominal aortic aneurysm repair or aorto-femoral/bi-femoral bypass for occlusive disease.
  4. Undergoing current chemotherapy or radiation therapy.
  5. Pregnancy or lactation.
  6. Inability or refusal to provide informed consent.
  7. Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days.
  8. Surgical incision in the groin without primary closure including previously open or infected wounds.
  9. Sensitivity or allergy to silver.
  10. Prior enrollment in this randomized controlled trial.

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): NCT02389023


Contacts
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Contact: Daniel J Bertges, MD 802-847-4548 daniel.bertges@uvmhealth.edu
Contact: Lisa A Smith, RN 802-656-9921 lisa.smith@med.uvm.edu

Locations
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United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Jens Eldrup-Joregensen, MD    207-774-6368    JorgeJ@mmc.org   
Contact: Louis Nguyen, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Keith Ozaki, MD    857-307-1920    CKOZAKI@PARTNERS.ORG   
Contact: Louis Nguyen, MD    857-307-1920    LNGUYEN@PARTNERS.ORG   
Beth Isreal Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mark Wyers, MD    617-632-9847    mwyers@bidmc.harvard.edu   
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Bjoern D Suckow, MD    603-650-8677    Bjoern.D.Suckow@hitchcock.org   
Contact: Wendy H Aarnio, RN    603-650-7966    Wendy.H.Aarnio@hitchcock.org   
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Lisa Smith, RN    802-656-9921    lisa.smith@uvm.edu   
Principal Investigator: Daniel Bertges, MD         
Sponsors and Collaborators
University of Vermont Medical Center
KCI USA, Inc.
MaineHealth
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Daniel J Bertges, MD University of Vermont Medical Center
Additional Information:
Publications:

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Responsible Party: Daniel Bertges, MD, Vascular Surgeon, University of Vermont Medical Center
ClinicalTrials.gov Identifier: NCT02389023    
Other Study ID Numbers: 15371
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Keywords provided by Daniel Bertges, MD, University of Vermont Medical Center:
surgical site infection
infrainguinal bypass
incisional wound vacuum assisted closure
Prevena
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases