Clinical trial NCT02399111: A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients
Official title: A Prospective Randomized Control Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Keywords: Prevena Incision Management System (PIMS)
Surgical Site Infection (SSI)
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Surgical site infection (SSI) in groin wounds after vascular surgery is a significant contributing factor for increased morbidity. Despite the use of prophylactic systemic antibiotics, postoperative groin wound infection still occurs in some circumstances and it continues to be a serious problem after vascular surgical procedures. The incidence of SSI varies from 5 - 40%, and depending upon the depth of infection and type of vascular procedure, the morbidity could range from prolonged hospital stay to limb loss.

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

Eligibility criteria: Inclusion Criteria:

1. Older than 18 years
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:

1. The patient has a history of blood clotting disorders
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

Primary outcomes:
measure: Incidence of Wound Infection With Szilagyi Grade
timeFrame: 30 days
Secondary outcomes:
measure: Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation
timeFrame: 30 days
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: North Shore-LIJ Health System
state: New York
Study officials:
affiliation: Northwell Health
name: Kambhampaty Krishnasastry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.