NCT04974931

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: St. James's Hospital, Ireland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Stoma Site Infection
• Ileostomy - Stoma
• Colostomy Stoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-04-01
• Completion: 2022-05-01
• First posted: 2021-07-23
• Last updated: 2021-09-21

Locations

1 site across 1 country: Ireland