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

NCT02389023 | Unknown

• 1 other identifier: 15371
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 5

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.

Conditions

Peripheral Artery Disease; Critical Limb Ischemia; Claudication

Keywords

surgical site infection; infrainguinal bypass; incisional wound vacuum assisted closure; Prevena

Outcome Measures

Primary Outcomes (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.

  30 days

Secondary Outcomes (5)

• surgical site infection alone at 30 days

  30 days

• patient satisfaction as assessed by quality of life survey

  30 days

• total costs including outpatient costs to 30 days postoperatively

  30 days

• length of index hospital stay and any readmission for wound complications

  30 days

• major adverse limb event (MALE) or postoperative death (POD). MALE includes above-ankle amputation of the index limb or major reintervention

  30 days

Study Arms (2)

standard gauze dressing

OTHER

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

Other: standard gauze dressing

Prevena Incision Management System

OTHER

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

Interventions

standard gauze dressing OTHER

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

standard gauze dressing

Prevena Incision Management system OTHER

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.

Prevena Incision Management System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vermont Medical Center: lead
• KCI USA, Inc: collaborator
• MaineHealth: collaborator
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (5)

Maine Medical Center

Portland, Maine, 04102, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 17606135 BACKGROUND

• 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.

  PMID: 18774446 BACKGROUND

• 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.

  PMID: 24953898 BACKGROUND

• 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.

  PMID: 9790339 BACKGROUND

• 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.

  PMID: 25175629 BACKGROUND

• 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.

  PMID: 18154995 BACKGROUND

• 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.

  PMID: 23312938 BACKGROUND

• Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

  PMID: 41159585 DERIVED

Related Links

• Prevention of infection in peripheral arterial reconstruction: a systematic review and meta-analysis. J Vasc Surg. 2007 Jul;46(1):148-55. Review.
• 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.
• Factors associated with surgical site infection after lower extremity bypass in the
• 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
• 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(
• 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
• 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

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Intermittent Claudication; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Signs and Symptoms; Wound Infection; Infections; Postoperative Complications

Study Officials

• Daniel J Bertges, MD

  University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel J Bertges, MD

CONTACT

802-847-4548; daniel.bertges@uvmhealth.edu

Lisa A Smith, RN

CONTACT

802-656-9921; lisa.smith@med.uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 17, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (5)