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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Application of PREVENA (Surgical Incision Protection System) in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy: A Randomized Controlled Trial (PRIC Trial)

Conditions
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Stoma Site Infection, Ileostomy - Stoma, Colostomy Stoma

Intervention / Treatment
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* Device: PREVENA Incision Management System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients applied with PREVENA system<br>This arm relates to the group of participants applied with PREVANA system post reversal of colostomy/ileostomy. | Device: PREVENA Incision Management System<br>* Eligible participants, i.e. participants meeting inclusive criteria, will be randomised in equal proportions and divided into two arms. The PREVENA dressings will be applied to the<br>* Other names: PREVENA Negative Pressure System;|
| No Intervention: Patients applied with conventional dressings<br>This arm relates to the group of participants applied with conventional dressings post reversal of colostomy/ileostomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure surgical site infection incidence on outpatient follow up post reversal ileostomy/colostomy | The investigators will be assessing and measuring the incidence of surgical site incidence on follow up appointments | Four to Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure surgical site infection incidence on day 5 post reversal ileostomy/colostomy (or earlier, if deemed fit for discharge prior to day 5) | The investigators will be assessing and measuring the incidence of surgical site incidence on day 5 post reversal ileostomy/colostomy | Five days post reversal ileostomy/colostomy | 
| To measure the time to wound healing | The investigators will be assessing and measuring the time to wound healing based on the duration and last appointment date of home visits by public healthcare nurses involving wound care management | One to Four weeks |