A Trial to Evaluate Negative Pressure Incision Management System for Groin

Status Terminated

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.

Clinical Trial 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 ;

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

Clinical Trial Details

NCT number	NCT02399111
Study type	Interventional
Source	Northwell Health
Contact
Status	Terminated
Phase	N/A
Start date	October 2013
Completion date	June 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms