A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients
NCT ID: NCT02399111
Last Updated: 2016-11-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2013-10-31
2015-06-30
Brief Summary
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Detailed Description
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Increased incidence of SSIs in patients is related to systemic factors like Diabetes, hypertension (HTN), history of smoking, chronic obstructive pulmonary disease (COPD), and local factors like disruption of lymphatics, groin proximity to the perineum, previous surgery at the same site and the use of prosthetic graft material.
Prophylactic systemic antibiotics have been routinely used in all vascular surgery procedures, and despite of gentle tissue handling, proper hemostasis and other technical points to minimize tissue trauma, SSIs do happen.
The investigators hypothesize that using a closed dressing system with negative pressure will keep the surgical site protected from nearby contaminated field and decrease the risk of infection
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Not obese:BMI<30; Standard Care
Standard Wound Care
No interventions assigned to this group
Obese:BMI≥30; Standard Care
Standard Wound Care
No interventions assigned to this group
Not Obese:BMI<30; Wound Vac
Using Prevena Incision Management System
Prevena Incision Management System
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.
Obese:BMI≥30; Wound Vac
Using Prevena Incision Management System
Prevena Incision Management System
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.
Interventions
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Prevena Incision Management System
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
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Inclusion Criteria
2. Subjects are capable of giving informed written consent
3. Undergoing a vascular surgery procedure that involves a groin incision at North Shore University Hospital and Long Island Jewish Hospital.
Exclusion Criteria
2. Patient has evidence of infection in the groin area, where surgical procedure is planned
3. Patient body habitus precludes placement of Prevena dressing.
4. Allergy to Silver or acrylic adhesive
18 Years
ALL
No
Sponsors
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Northwell Health
OTHER
Responsible Party
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Kambhampaty Krishnasastry
MD
Principal Investigators
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Kambhampaty Krishnasastry, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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North Shore-LIJ Health System
Lake Success, New York, United States
Countries
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References
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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.
Colli 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.
Other Identifiers
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13-485
Identifier Type: -
Identifier Source: org_study_id