Ileostomy - Stoma Clinical Trial
— PRICOfficial 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)
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.
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 |
Country | Name | City | State |
---|---|---|---|
Ireland | St James's Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
St. James's Hospital, Ireland |
Ireland,
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 |
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