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

Not Applicable

• Conditions: Colostomy Stoma; Ileostomy - Stoma; Stoma Site Infection
• Interventions: Device: PREVENA Incision Management System

• Registration Number: NCT04974931
• Lead Sponsor: St. James's Hospital, Ireland

Brief Summary

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

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)

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Study Start: 2021-11-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients applied with PREVENA system	PREVENA Incision Management System	This arm relates to the group of participants applied with PREVANA system post reversal of colostomy/ileostomy.

Primary Outcome Measures

Name	Time	Method
To measure surgical site infection incidence on outpatient follow up post reversal ileostomy/colostomy	Four to Six weeks	The investigators will be assessing and measuring the incidence of surgical site incidence on follow up appointments

Secondary Outcome Measures

Name	Time	Method
To measure the time to wound healing	One to Four weeks	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
To measure surgical site infection incidence on day 5 post reversal ileostomy/colostomy (or earlier, if deemed fit for discharge prior to day 5)	Five days post reversal ileostomy/colostomy	The investigators will be assessing and measuring the incidence of surgical site incidence on day 5 post reversal ileostomy/colostomy

Trial Locations

Locations (1)

St James's Hospital; 🇮🇪 Dublin, Ireland