Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy (PRIC)

St. James's Hospital, Ireland

Status: Unknown

Conditions: Ileostomy - Stoma; Colostomy Stoma; Stoma Site Infection

Treatments: Device: PREVENA Incision Management System

Study type: Interventional

Funder types: Other

Identifiers

NCT04974931

St James Hospital

Details and patient eligibility

About

Surgical site infections (SSI) remain one of the most common complications associated with reversal of ileostomy and colostomy. In addition to having detrimental impacts on the patient's post-operative course, they also pose significant financial ramifications.

There have been comparative studies in the use of negative pressure wound therapy in reducing surgical site infections.

PREVENA Incision Management System is a type of disposable, customizable and powered negative pressure system designed to help manage and protect surgical incisions and their surrounding environment. It is now commonly used as a surgical wound dressings in the setting of vascular surgeries, post-cesarean infections and colorectal resections.

Our study is designed as a randomised controlled trial to examine if PREVERA therapy as a NPWT is more superior than conventional dressings in reducing the rate of surgical site infections.

Full description

Background:

Surgical site infections (SSI) remain one of the most common complications associated with reversal of ileostomy. In addition to having detrimental impacts on the patient's post-operative course, they also pose significant financial ramifications.

The use of Negative Pressure Wound Therapy (NPWT) is one strategy that has been extensively studied in reducing the rate of surgical site infections.

PREVENA Therapy is a form of Incisional Negative Pressure Wound Therapy (INPWT) that has been widely used in the management of closed surgical incisions. They are delivered as prophylactic measures in preventing surgical complications such as surgical site infections.

Trial Design:

This study is designed as a randomized, controlled, open-label, multi-center superiority trial with 2 parallel groups and primary endpoint of surgical site infection at day 7 (after 7-day use of PREVENA) and day 30.

Study Setting The trial will be conducted at two different hospitals located in Dublin, Ireland: St James Hospital - Ireland's largest acute academic teaching hospital (Academic Partner - Trinity College Dublin); Tallaght University Hospital - (Academic Partner - Trinity College Dublin)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged over 18 years old
• Patients undergoing elective reversal of ileostomy/colostomy
• Patients who agree to consent to inclusion and follow-up protocol

Exclusion criteria

• Patients who do not fulfil study protocol
• Dressings being removed outside defined time periods
• Patients who do not attend for regular outpatient follow up appointments

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Patients applied with PREVENA system

Active Comparator group

Description:

This arm relates to the group of participants applied with PREVANA system post reversal of colostomy/ileostomy.

Treatment:

Device: PREVENA Incision Management System

Patients applied with conventional dressings

No Intervention group

Description:

This arm relates to the group of participants applied with conventional dressings post reversal of colostomy/ileostomy