RecruitingNot Applicable

Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)

Canada68 participantsStarted 2024-10-22

Plain-language summary

The aim of the study is to compare outcomes between patients receiving standard C-section wound closure compared to a wound closure bundle that includes Stratafix sutures and Dermabond PRINEO.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient must be 18 years of age or older at time of recruitment
. Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent.
. Patients must have internet access and/or a smartphone in order to access the digital platform to complete the study questionnaires
. Patients must speak and write in English as study questionnaires will only be provided in English
. Patients must have coverage from the Ontario Health Insurance Plan (OHIP)

Exclusion criteria

. Patients assessed by the participating surgeon with any conditions that may compromise their:
. Patients who enroll in the study but have an unplanned emergency C-section

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Canadian Patient Experiences Survey - Inpatient Care + maternity questions

Timeframe: Assessed roughly 48-72 hours after C-section delivery

SCAR-Q Scores

Timeframe: Assessed at approximately 6 week follow-up appointment

Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]

Timeframe: Assessed at approximately 6 week follow-up appointment

Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment]

Timeframe: Assessed at approximately 6 week follow-up appointment

Antibiotic prescription for treatment of infection [Surgical site infection questionnaire completed at follow-up appointment]

Timeframe: Assessed at approximately 6 week follow-up appointment

Trial details

NCT IDNCT06614829

SponsorNorth York General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Mark Fan, MHSc

416-756-6000 humanera@nygh.on.ca

View on ClinicalTrials.gov More Cesarean Section; Complications, Wound, Infection (Following Delivery) trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient must be 18 years of age or older at time of recruitment
. Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent.
. Patients must have internet access and/or a smartphone in order to access the digital platform to complete the study questionnaires
. Patients must speak and write in English as study questionnaires will only be provided in English
. Patients must have coverage from the Ontario Health Insurance Plan (OHIP)

Exclusion criteria

. Patients assessed by the participating surgeon with any conditions that may compromise their:
. Patients who enroll in the study but have an unplanned emergency C-section

What they're measuring

Canadian Patient Experiences Survey - Inpatient Care + maternity questions

Timeframe: Assessed roughly 48-72 hours after C-section delivery

SCAR-Q Scores

Timeframe: Assessed at approximately 6 week follow-up appointment

Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]

Timeframe: Assessed at approximately 6 week follow-up appointment

Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment]

Timeframe: Assessed at approximately 6 week follow-up appointment

Antibiotic prescription for treatment of infection [Surgical site infection questionnaire completed at follow-up appointment]

Timeframe: Assessed at approximately 6 week follow-up appointment