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

Ileostomy - Stoma Clinical Trial

— PRIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04974931
• Other study ID #: St James Hospital
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2021
• Source: St. James's Hospital, Ireland
• Contact: Ernest Low
• Phone: +353 (01) 410 3000
• Email: lowe[@]tcd.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colostomy Stoma
• Ileostomy - Stoma
• Stoma Site Infection

Intervention

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

Locations

Country	Name	City	State
Ireland	St James's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
St. James's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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