Stoma Site InfectionPRICNCT04974931
Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy
A study testing PREVENA Incision Management System in people with Stoma Site Infection and Ileostomy - Stoma, run by St. James's Hospital, Ireland at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Site Infection, Ileostomy - Stoma, Colostomy Stoma
- What is being tested?
- PREVENA Incision Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 1 Nov 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years old
- Patients undergoing elective reversal of ileostomy/colostomy
- Patients who agree to consent to inclusion and follow-up protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site
St James's Hospital
Dublin, D08 NHY1
Ernest Low, +353 (01) 410 3000
About this study
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)
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.
Read more
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.
Read the 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
- Being tested
- PREVENA Incision Management System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENA Incision Management SystemDevice
Also called PREVENA Negative Pressure 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
| Study group | Role | What they receive |
|---|---|---|
| Patients applied with PREVENA system | Active comparator | This arm relates to the group of participants applied with PREVANA system post reversal of colostomy/ileostomy. Receives: Device: PREVENA Incision Management System |
| Patients applied with conventional dressings | No intervention | This arm relates to the group of participants applied with conventional dressings post reversal of colostomy/ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Four to Six weeks
Secondary outcomes (2)
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
Measured: Five days post reversal ileostomy/colostomy
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
Measured: One to Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kelly, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974931
- Sponsor's protocol ID
- St James Hospital
- Acronym
- PRIC
- Status last verified
- Sep 2021
- First submitted
- 16 Jul 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04974931
- Acronym / sponsor ID
- PRIC / St James Hospital
- Conditions
- Stoma Site Infection, Ileostomy - Stoma, Colostomy Stoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients applied with PREVENA system | Active comparator | Device: PREVENA Incision Management SystemThis arm relates to the group of participants applied with PREVANA system post reversal of colostomy/ileostomy. |
| Patients applied with conventional dressings | No intervention | –This arm relates to the group of participants applied with conventional dressings post reversal of colostomy/ileostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged over 18 years old
- Patients undergoing elective reversal of ileostomy/colostomy
- Patients who agree to consent to inclusion and follow-up protocol
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVENA Incision Management SystemAlso: PREVENA Negative Pressure SystemEligible 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 | Device | Patients applied with PREVENA system |
Primary outcome
To measure surgical site infection incidence on outpatient follow up post reversal ileostomy/colostomy
Time frame: Four to Six weeks
The investigators will be assessing and measuring the incidence of surgical site incidence on follow up appointments
2 secondary outcomes
To measure surgical site infection incidence on day 5 post reversal ileostomy/colostomy (or earlier, if deemed fit for discharge prior to day 5)
Time frame: Five days post reversal ileostomy/colostomy
To measure the time to wound healing
Time frame: One to Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Related trials for Stoma Site Infection
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVENA Incision Management System in people with Stoma Site Infection and Ileostomy - Stoma, run by St. James's Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ernest Low (+353 (01) 410 3000, lowe@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure surgical site infection incidence on outpatient follow up post reversal ileostomy/colostomy (time frame: Four to Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.