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

NCT04974931 | Unknown DMC

• 1 other identifier: St James Hospital
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stoma Site Infection; Ileostomy - Stoma; Colostomy Stoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• To measure the time to wound healing

  One to Four weeks

Study Arms (2)

Patients applied with PREVENA system

ACTIVE COMPARATOR

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

Device: PREVENA Incision Management System

Patients applied with conventional dressings

NO INTERVENTION

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

Interventions

PREVENA Incision Management System DEVICE

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

Also known as: PREVENA Negative Pressure System

Patients applied with PREVENA system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18 years old
• Patients undergoing elective reversal of ileostomy/colostomy

You may not qualify if:

• 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

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead

Study Sites (1)

St James's Hospital

Dublin, D08 NHY1, Ireland

Location

Central Study Contacts

Ernest Low

CONTACT

+353 (01) 410 3000; lowe@tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Colorectal Surgeon

Model Details: 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 Record Dates

• First Submitted: July 16, 2021
• First Posted: July 23, 2021
• Study Start: November 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

IE (1)