Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
NCT ID: NCT02389023
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
242 participants
INTERVENTIONAL
2015-09-30
2019-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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standard gauze dressing
a standard post-operative dressing consisting of dry gauze and tape will be placed over the surgical site
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.
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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KCI USA, Inc
INDUSTRY
MaineHealth
OTHER
Brigham and Women's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
University of Vermont Medical Center
OTHER
Responsible Party
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Daniel Bertges, MD
Vascular Surgeon
Principal Investigators
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Daniel J Bertges, MD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont Medical Center
Locations
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Maine Medical Center
Portland, Maine, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Jens Eldrup-Joregensen, MD
Role: primary
Louis Nguyen, MD
Role: backup
Keith Ozaki, MD
Role: primary
Louis Nguyen, MD
Role: backup
Mark Wyers, MD
Role: primary
Bjoern D Suckow, MD
Role: primary
Wendy H Aarnio, RN
Role: backup
Lisa Smith, RN
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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:CD015022. doi: 10.1002/14651858.CD015022.pub2.
Related Links
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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
Other Identifiers
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15371
Identifier Type: -
Identifier Source: org_study_id