NCT02836990

Brief Summary

This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 28, 2020

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

3.2 years

First QC Date

July 11, 2016

Results QC Date

February 25, 2020

Last Update Submit

December 23, 2020

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

  • Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond

    The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision). Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection. Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.

    30 days

Secondary Outcomes (2)

  • Cost of Care

    30 days

  • Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection

    30 days

Study Arms (2)

Prevena

ACTIVE COMPARATOR

Prevena Incision Management System for vascular surgical groin wounds

Device: Prevena Incision Management System

Dermabond

ACTIVE COMPARATOR

Dermabond for vascular surgical groin wounds

Device: Dermabond

Interventions

Prevena Incision Management SystemDEVICE

A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections

Also known as: Prevena
Prevena
DermabondDEVICE

A surgical skin adhesive used to prevent surgical wound infections

Dermabond

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In need of elective vascular procedure requiring ≥8 cm groin incision.
  • Able to provide consent
  • Able to care for wound or have support person to complete wound care
  • Willing to comply with follow-up

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaleida Health, Gates Vascular Institute

Buffalo, New York, 14203, United States

Location

State University of New York at Buffalo

Buffalo, New York, 14203, United States

Location

Related Publications (16)

  • Ploeg AJ, Lardenoye JW, Peeters MP, Hamming JF, Breslau PJ. Wound complications at the groin after peripheral arterial surgery sparing the lymphatic tissue: a double-blind randomized clinical trial. Am J Surg. 2009 Jun;197(6):747-51. doi: 10.1016/j.amjsurg.2008.04.014. Epub 2008 Oct 17.

    PMID: 18929355BACKGROUND

  • Lee ES, Santilli SM, Olson MM, Kuskowski MA, Lee JT. Wound infection after infrainguinal bypass operations: multivariate analysis of putative risk factors. Surg Infect (Larchmt). 2000 Winter;1(4):257-63. doi: 10.1089/109629600750067183.

    PMID: 12594881BACKGROUND

  • Lawlor DK, Derose G, Harris KA, Lovell MB, Novick TV, Forbes TL. The role of platelet-rich plasma in inguinal wound healing in vascular surgery patients. Vasc Endovascular Surg. 2011 Apr;45(3):241-5. doi: 10.1177/1538574411399157.

    PMID: 21478245BACKGROUND

  • Exton RJ, Galland RB. Major groin complications following the use of synthetic grafts. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):188-90. doi: 10.1016/j.ejvs.2007.03.012. Epub 2007 May 18.

    PMID: 17512763BACKGROUND

  • Engin C, Posacioglu H, Ayik F, Apaydin AZ. Management of vascular infection in the groin. Tex Heart Inst J. 2005;32(4):529-34.

    PMID: 16429897BACKGROUND

  • 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: 18774446BACKGROUND

  • Swinnen J, Chao A, Tiwari A, Crozier J, Vicaretti M, Fletcher J. Vertical or transverse incisions for access to the femoral artery: a randomized control study. Ann Vasc Surg. 2010 Apr;24(3):336-41. doi: 10.1016/j.avsg.2009.07.020. Epub 2009 Dec 4.

    PMID: 19962270BACKGROUND

  • Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML. Management of early (<30 day) vascular groin infections using vacuum-assisted closure alone without muscle flap coverage in a consecutive patient series. J Vasc Surg. 2010 May;51(5):1160-6. doi: 10.1016/j.jvs.2009.11.053. Epub 2010 Mar 31.

    PMID: 20356703BACKGROUND

  • Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.

    PMID: 10219875BACKGROUND

  • Easterlin B, Bromberg W, Linscott J. A Novel Technique of Vacuum-assisted Wound Closure That Functions as a Delayed Primary Closure. Wounds. 2007 Dec;19(12):331-3.

    PMID: 25942681BACKGROUND

  • de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.

    PMID: 19398246BACKGROUND

  • Weir G. The use of a surgical incision management system on vascular surgery incisions: a pilot study. Int Wound J. 2014 Jun;11 Suppl 1(Suppl 1):10-2. doi: 10.1111/iwj.12261.

    PMID: 24851730BACKGROUND

  • 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: 23312938BACKGROUND

  • Bruns TB, Worthington JM. Using tissue adhesive for wound repair: a practical guide to dermabond. Am Fam Physician. 2000 Mar 1;61(5):1383-8.

    PMID: 10735344BACKGROUND

  • 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: 41159585DERIVED

  • Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.

    PMID: 40260835DERIVED

Related Links

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

Title
Dr Linda Harris
Organization
University at Buffalo, SUNY
lmharris@buffalo.edu
7168594207

Study Officials

  • Linda Harris, MD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Professor

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 19, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

December 28, 2020

Results First Posted

December 28, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)