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

September 20, 2021 updated by: Michael Kelly, St. James's Hospital, Ireland

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ernest Low
  • Phone Number: +353 (01) 410 3000
  • Email: lowe@tcd.ie

Study Locations

  • Ireland
      • Dublin, Ireland, D08 NHY1
        • St James's Hospital
        • Contact:
          • Ernest Low
          • Phone Number: +353 (01) 410 3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients applied with PREVENA system
This arm relates to the group of participants applied with PREVANA system post reversal of colostomy/ileostomy.
Device: PREVENA Incision Management System
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
Other Names:
  • PREVENA Negative Pressure System
No Intervention: Patients applied with conventional dressings
This arm relates to the group of participants applied with conventional dressings post reversal of colostomy/ileostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure surgical site infection incidence on outpatient follow up post reversal ileostomy/colostomy
Time Frame: Four to Six weeks
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)
Time Frame: 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
Five days post reversal ileostomy/colostomy
To measure the time to wound healing
Time Frame: 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
One to Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. James's Hospital, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • St James Hospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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