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

Primary Purpose

Peripheral Artery Disease, Critical Limb Ischemia, Claudication

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard gauze dressing
Prevena Incision Management system
Sponsored by
University of Vermont Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Artery Disease focused on measuring surgical site infection, infrainguinal bypass, incisional wound vacuum assisted closure, Prevena

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maine Medical CenterRecruiting
  • Brigham and Women's HospitalRecruiting
  • Beth Isreal Deaconess Medical CenterRecruiting
  • Dartmouth Hitchcock Medical CenterRecruiting
  • University of Vermont Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

standard gauze dressing

Prevena Incision Management System

Arm Description

a standard post-operative dressing consisting of dry gauze and tape will be placed over the surgical site

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

surgical site infection alone at 30 days
patient satisfaction as assessed by quality of life survey
total costs including outpatient costs to 30 days postoperatively
length of index hospital stay and any readmission for wound complications
major adverse limb event (MALE) or postoperative death (POD). MALE includes above-ankle amputation of the index limb or major reintervention

Full Information

First Posted
March 9, 2015
Last Updated
December 11, 2018
Sponsor
University of Vermont Medical Center
Collaborators
3M, MaineHealth, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02389023
Brief Title
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
Official Title
Multicenter, Prospective, Randomized Clinical Trial of a Negative Pressure Incision Management System in High Risk Vascular Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont Medical Center
Collaborators
3M, MaineHealth, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Complications such as surgical site infections, deep wound infections, prosthetic graft infections, and non-infections problems such as wound dehiscence continue to cause significant morbidity for patients undergoing arterial reconstruction for peripheral arterial disease. Patients undergoing leg bypass surgery for limb salvage are at particular risk due to their medical problems such as diabetes and renal failure and location of incisions along the groin area. Surgical site infections (SSI) are estimated to occur in 5-40% of patients undergoing arterial bypass for lower extremity arterial occlusive disease. The in-hospital SSI rate is 5% across the Vascular Study Group of New England, a regional quality improvement registry. Factors contributing to wound infections include patient factors such as advanced age and comorbidities such as obesity, diabetes and renal insufficiency and surgical factors including the division of local lymphatics in the groin, placement of a prosthetic graft and inherent difficulty in keeping an incision across the groin crease covered, dry and protected. Despite the use of standard sterile technique and perioperative preventative antibiotics infections these complications continue to cause patient morbidity. In addition these complications increase the intensity and cost of care with an added estimated expense of $11,000 per incident. New strategies are needed to reduce these complications. Negative pressure wound therapy has the potential to prevent a variety of wound complications. One innovative strategy that has shown promise is the application of 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. When compared to surgical dressing with sterile gauze and tape, the Prevena dressing system has the advantages of providing a sterile barrier, reducing tension on the incision, and removing fluid from the incision. Please refer to patient brochure for an illustration and further description of the Prevena dressing system. Negative pressure wound therapy has been applied for many years to enhance healing of a variety of open wounds including pressure wounds, diabetic ulcers, venous stasis ulcers, open infected surgical to traumatic wounds and burns with variable success. The treatment is based on evenly distributed local negative pressure applied to the wound surface. The open wound is filled with a sponge and covered with an occlusive dressing which is then connected by means of a set of suction tubes to a device which applies negative pressure on the surface of the wound that can be adjusted either cyclically or continuously. The fluid from the wound is collected into a container. The benefits of negative pressure wound therapy have been reported to include removal of infectious material, reduction in edema and improved perfusion to tissue. The success of negative pressure wound therapy with open wounds has been extrapolated to intact surgical incisions. Recently a negative pressure wound therapy dressing has been developed for use over closed surgical incisions. The investigators aim to study the ability of a negative pressure wound therapy dressing to prevent wound complications after vascular surgery involving incisions in the groin. The aim of this study is to compare the Prevena dressing system to standard surgical dressing in patients undergoing leg bypass surgery or femoral endarterectomy with or without patch angioplasty involving the common femoral artery and/or profunda and/or proximal superficial femoral 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) as well as bilateral femoral endartectomies are eligible for enrollment. The right and left groin incision would be randomized to the same dressing which is consistent with routine clinical practice. for vascular disease involving their legs in a multicenter randomized trial. All other aspects of the procedure are the part of standard vascular surgery practice. Patients undergoing vascular surgery with an incision in the groin will be treated with a standard gauze dressing or the Prevena wound management system which will be applied in the operating room and left on the wound for 5-7 days. Follow-up visits to assess the surgical wound are already standard of care. The two groups will be compared based on the primary and secondary endpoints listed in these documents. Quality of life will be compared by a patient survey and a cost analysis will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Critical Limb Ischemia, Claudication
Keywords
surgical site infection, infrainguinal bypass, incisional wound vacuum assisted closure, Prevena

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard gauze dressing
Arm Type
Other
Arm Description
a standard post-operative dressing consisting of dry gauze and tape will be placed over the surgical site
Arm Title
Prevena Incision Management System
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
standard gauze dressing
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Prevena Incision Management system
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
surgical site infection alone at 30 days
Time Frame
30 days
Title
patient satisfaction as assessed by quality of life survey
Time Frame
30 days
Title
total costs including outpatient costs to 30 days postoperatively
Time Frame
30 days
Title
length of index hospital stay and any readmission for wound complications
Time Frame
30 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 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. 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. Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent. Exclusion Criteria: Any groin incision on index leg within 12 weeks prior to treatment initiation. Infrainguinal bypass without a groin incision including popliteal-tibial or pedal bypass. Supra inguinal procedures such as open or endovascular abdominal aortic aneurysm repair or aorto-femoral/bi-femoral bypass for occlusive disease. Undergoing current chemotherapy or radiation therapy. Pregnancy or lactation. Inability or refusal to provide informed consent. 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. Surgical incision in the groin without primary closure including previously open or infected wounds. Sensitivity or allergy to silver. Prior enrollment in this randomized controlled trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel J Bertges, MD
Phone
802-847-4548
Email
daniel.bertges@uvmhealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa A Smith, RN
Phone
802-656-9921
Email
lisa.smith@med.uvm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Bertges, MD
Organizational Affiliation
University of Vermont Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Eldrup-Joregensen, MD
Phone
207-774-6368
Email
JorgeJ@mmc.org
First Name & Middle Initial & Last Name & Degree
Louis Nguyen, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Ozaki, MD
Phone
857-307-1920
Email
CKOZAKI@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Louis Nguyen, MD
Phone
857-307-1920
Email
LNGUYEN@PARTNERS.ORG
Facility Name
Beth Isreal Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Wyers, MD
Phone
617-632-9847
Email
mwyers@bidmc.harvard.edu
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjoern D Suckow, MD
Phone
603-650-8677
Email
Bjoern.D.Suckow@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Wendy H Aarnio, RN
Phone
603-650-7966
Email
Wendy.H.Aarnio@hitchcock.org
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Smith, RN
Phone
802-656-9921
Email
lisa.smith@uvm.edu
First Name & Middle Initial & Last Name & Degree
Daniel Bertges, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17606135
Citation
Stewart AH, Eyers PS, Earnshaw JJ. Prevention of infection in peripheral arterial reconstruction: a systematic review and meta-analysis. J Vasc Surg. 2007 Jul;46(1):148-55. doi: 10.1016/j.jvs.2007.02.065.
Results Reference
background
PubMed Identifier
18774446
Citation
Bandyk DF. Vascular surgical site infection: risk factors and preventive measures. Semin Vasc Surg. 2008 Sep;21(3):119-23. doi: 10.1053/j.semvascsurg.2008.05.008.
Results Reference
background
PubMed Identifier
24953898
Citation
Kalish JA, Farber A, Homa K, Trinidad M, Beck A, Davies MG, Kraiss LW, Cronenwett JL; Society for Vascular Surgery Patient Safety Organization Arterial Quality Committee. Factors associated with surgical site infection after lower extremity bypass in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI). J Vasc Surg. 2014 Nov;60(5):1238-1246. doi: 10.1016/j.jvs.2014.05.012. Epub 2014 Jun 20.
Results Reference
background
PubMed Identifier
9790339
Citation
Khuri SF, Daley J, Henderson W, Hur K, Demakis J, Aust JB, Chong V, Fabri PJ, Gibbs JO, Grover F, Hammermeister K, Irvin G 3rd, McDonald G, Passaro E Jr, Phillips L, Scamman F, Spencer J, Stremple JF. The Department of Veterans Affairs' NSQIP: the first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. National VA Surgical Quality Improvement Program. Ann Surg. 1998 Oct;228(4):491-507. doi: 10.1097/00000658-199810000-00006.
Results Reference
background
PubMed Identifier
25175629
Citation
Ozaki CK, Hamdan AD, Barshes NR, Wyers M, Hevelone ND, Belkin M, Nguyen LL. Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications. J Vasc Surg. 2015 Feb;61(2):419-427.e1. doi: 10.1016/j.jvs.2014.07.034. Epub 2014 Aug 28.
Results Reference
background
PubMed Identifier
18154995
Citation
Nguyen LL, Brahmanandam S, Bandyk DF, Belkin M, Clowes AW, Moneta GL, Conte MS. Female gender and oral anticoagulants are associated with wound complications in lower extremity vein bypass: an analysis of 1404 operations for critical limb ischemia. J Vasc Surg. 2007 Dec;46(6):1191-1197. doi: 10.1016/j.jvs.2007.07.053.
Results Reference
background
PubMed Identifier
23312938
Citation
Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Stewart+AH%2C+Eyers+PS%2C+Earnshaw+JJ.+Prevention+of+infection+in+peripheral+arterial+reconstruction%3A+a+systematic+review+and+meta-analysis.+J+Vasc+Surg.+2007+Jul%3B46(1)%3A148-55.+Review.
Description
Prevention of infection in peripheral arterial reconstruction: a systematic review and meta-analysis. J Vasc Surg. 2007 Jul;46(1):148-55. Review.
URL
http://www.ncbi.nlm.nih.gov/pubmed/18774446
Description
Vascular surgical site infection: risk factors and preventive measures. Semin Vasc Surg. 2008 Sep;21(3):119-23. doi: 10.1053/j.semvascsurg.2008.05.008. Review.
URL
http://www.ncbi.nlm.nih.gov/pubmed/24953898
Description
Factors associated with surgical site infection after lower extremity bypass in the
URL
http://www.ncbi.nlm.nih.gov/pubmed/9790339
Description
The Department of Veterans Affairs' NSQIP: the first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. National VA Surgical Quality Improvement Program. Ann
URL
http://www.ncbi.nlm.nih.gov/pubmed/25175629
Description
Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications. J Vasc Surg. 2015 Feb;61(
URL
http://www.ncbi.nlm.nih.gov/pubmed/18154995
Description
Female gender and oral anticoagulants are associated with wound complications in lower extremity vein bypass: an analysis of 1404 operations for critical limb ischemia. J Vasc
URL
http://www.ncbi.nlm.nih.gov/pubmed?term=%22Journal+of+vascular+surgery%22%5BJour%5D+AND+matatov%5Bauthor%5D&cmd=detailssearch
Description
Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. E

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

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