Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy
NCT ID: NCT04974931
Last Updated: 2021-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-11-01
2022-05-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Patients applied with PREVENA system
This arm relates to the group of participants applied with PREVANA system post reversal of colostomy/ileostomy.
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
Patients applied with conventional dressings
This arm relates to the group of participants applied with conventional dressings post reversal of colostomy/ileostomy
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective reversal of ileostomy/colostomy
* Patients who agree to consent to inclusion and follow-up protocol
Exclusion Criteria
* Dressings being removed outside defined time periods
* Patients who do not attend for regular outpatient follow up appointments
18 Years
ALL
No
Sponsors
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St. James's Hospital, Ireland
OTHER
Responsible Party
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Michael Kelly
Consultant Colorectal Surgeon
Locations
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St James's Hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Ernest Low
Role: primary
Other Identifiers
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St James Hospital
Identifier Type: -
Identifier Source: org_study_id
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