Study Stopped
PI Decision
A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients
A Prospective Randomized Control Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients
1 other identifier
interventional
9
1 country
1
Brief Summary
The purpose of this research study is to investigate if a new negative pressure incision (surgical cut) management system, could reduce the occurrence of groin wound infections after vascular surgery. This is a single use, sterile dressing that is applied to the patient's skin. It has an attached battery-powered unit that provides negative pressure (a vacuum environment) to the dressing and a disposable canister for the collection of wound fluids. The patient is being asked to participate in this study because the patient is planning to have a vascular surgery procedure that involves groin incision.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
1 active site
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
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
November 21, 2016
CompletedNovember 21, 2016
November 1, 2016
1.7 years
February 24, 2015
November 16, 2016
November 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Wound Infection With Szilagyi Grade
This study was terminated prior to gathering of data.
30 days
Secondary Outcomes (1)
Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation
30 days
Study Arms (4)
Not obese:BMI<30; Standard Care
NO INTERVENTIONStandard Wound Care
Obese:BMI≥30; Standard Care
NO INTERVENTIONStandard Wound Care
Not Obese:BMI<30; Wound Vac
OTHERUsing Prevena Incision Management System
Obese:BMI≥30; Wound Vac
OTHERUsing Prevena Incision Management System
Interventions
The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
Eligibility Criteria
You may qualify if:
- Older than 18 years
- Subjects are capable of giving informed written consent
- Undergoing a vascular surgery procedure that involves a groin incision at North Shore University Hospital and Long Island Jewish Hospital.
You may not qualify if:
- The patient has a history of blood clotting disorders
- Patient has evidence of infection in the groin area, where surgical procedure is planned
- Patient body habitus precludes placement of Prevena dressing.
- Allergy to Silver or acrylic adhesive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
North Shore-LIJ Health System
Lake Success, New York, 11042, United States
Related Publications (2)
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: 23312938BACKGROUNDColli A, Camara ML. First experience with a new negative pressure incision management system on surgical incisions after cardiac surgery in high risk patients. J Cardiothorac Surg. 2011 Dec 6;6:160. doi: 10.1186/1749-8090-6-160.
PMID: 22145641BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kambhampaty Krishnasastry
- Organization
- Northwell Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Kambhampaty Krishnasastry, MD
Northwell Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 24, 2015
First Posted
March 26, 2015
Study Start
October 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 21, 2016
Results First Posted
November 21, 2016
Record last verified: 2016-11