Clinical trial NCT04974931: Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stoma Site Infection
Ileostomy - Stoma
Colostomy Stoma
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: To measure surgical site infection incidence on outpatient follow up post reversal ileostomy/colostomy
timeFrame: Four to Six weeks
Secondary outcomes:
measure: To measure surgical site infection incidence on day 5 post reversal ileostomy/colostomy (or earlier, if deemed fit for discharge prior to day 5)
timeFrame: Five days post reversal ileostomy/colostomy
measure: To measure the time to wound healing
timeFrame: One to Four weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St James's Hospital
Study officials:
References: