A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients

Surgical Procedure, Unspecified Clinical Trial

Official title:

A Prospective Randomized Control Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02399111
• Other study ID #: 13-485
• Status: Terminated
• Phase: N/A
• First received: February 24, 2015
• Last updated: November 18, 2016
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	North Shore-LIJ Health System	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum in: J Cardiothorac Surg. 2012;7:37. Camara, Maria-Luisa [added]. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Wound Infection With Szilagyi Grade	This study was terminated prior to gathering of data.	30 days	Yes
Secondary	Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation	This study was terminated prior to collection of data.	30 days	Yes