Cesarean Section; Complications, Wound, Infection (Following Delivery)CS-PREONCT06614829
Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)
A study testing Stratafix Suture and DERMABOND PRINEO in people with Cesarean Section; Complications, Wound, Infection (Following Delivery), run by North York General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section; Complications, Wound, Infection (Following Delivery)
- What is being tested?
- Stratafix Suture and DERMABOND PRINEO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients assessed by the participating surgeon with any conditions that may compromise their:
- Ability to consent or use the virtual care platform (e.g., patients with intellectual disabilities)
- Expectation of significant maternal complications that may affect the surgery
- Patients who enroll in the study but have an unplanned emergency C-section
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
North York General Hospital
North York, Ontario, M2K1E1
Mark Fan, 416-756-6000, clinicaltrials@nygh.on.ca
About this study
Official title: Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle
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.
Read the detailed description
The purpose of this study is to evaluate patient experience and patient reported outcomes following cesarean delivery in women receiving either standard wound closure or a wound closure bundle which includes both Stratfix sutures and Dermabond Prineo.
Patients in both study arms will complete established questionnaires capturing patient-reported experience measures (PREMS) and patient-reported outcome measures (PROMS).
- Being tested
- Stratafix Suture, DERMABOND PRINEO
- Medical subject headings
- Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratafix SutureDevice
Stratafix sutures are barbed and have an antimicrobial coating. The barbs maintain tension during and allows for knotless suturing. The antimicrobial coating inhibits bacterial colonization of the wound.
DERMABOND PRINEODevice
DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive. It also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment until the liquid adhesive is applied to achieve skin closure. It forms a strong, flexible, waterproof microbial barrier-as long as the adhesive film remains intact-that falls off naturally after 7-14 days.
Dermabond Prineo system will be applied to the skin for skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group would be receiving the standard of care. |
| Bundled C-section Wound Closure | Active comparator | Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing. Receives: Device: Stratafix Suture; Device: DERMABOND PRINEO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Patient Experiences Survey - Inpatient Care + maternity questions
Validated patient reported experience measure (PREM) assessing 1) communication with nurses, 2) communication with doctors, 3) involvement in decision-making and treatment options, 4) information and understanding when leaving the hospital, and 5) overall hospital experience
Measured: Assessed roughly 48-72 hours after C-section delivery
SCAR-Q Scores
Validated patient reported outcome measure (PROM) assessing three domains: 1) Scar appearance, 2) Scar Symptoms, and 3) Psychosocial Impact
Measured: Assessed at approximately 6 week follow-up appointment
Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]
Categories include: no, superficial, deep, organ/space
Measured: Assessed at approximately 6 week follow-up appointment
Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment]
Self-reported by patient
Measured: Assessed at approximately 6 week follow-up appointment
Antibiotic prescription for treatment of infection [Surgical site infection questionnaire completed at follow-up appointment]
Self-reported by patient
Measured: Assessed at approximately 6 week follow-up appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start22 Oct 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; Complications, Wound, Infection (Following Delivery)Studies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel between group study
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North York General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Patricia Trbovich, North York General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614829
- Sponsor's protocol ID
- 0434
- Acronym
- CS-PREO
- Status last verified
- Nov 2024
- First submitted
- 24 Sep 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only aggregate data will be shared comparing study arms.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle
- ClinicalTrials.gov ID
- NCT06614829
- Acronym / sponsor ID
- CS-PREO / 0434
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- North York General HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Sep 2024 (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.
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.
Detailed description
The purpose of this study is to evaluate patient experience and patient reported outcomes following cesarean delivery in women receiving either standard wound closure or a wound closure bundle which includes both Stratfix sutures and Dermabond Prineo.
Patients in both study arms will complete established questionnaires capturing patient-reported experience measures (PREMS) and patient-reported outcome measures (PROMS).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel between group study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group would be receiving the standard of care. |
| Bundled C-section Wound Closure | Active comparator | Device: Stratafix Suture, Device: DERMABOND PRINEOSurgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Stratafix SutureStratafix sutures are barbed and have an antimicrobial coating. The barbs maintain tension during and allows for knotless suturing. The antimicrobial coating inhibits bacterial colonization of the wound. | Device | Bundled C-section Wound Closure |
| DERMABOND PRINEODERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive. It also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment until the liquid adhesive is applied to achieve skin closure. It forms a strong, flexible, waterproof microbial barrier-as long as the adhesive film remains intact-that falls off naturally after 7-14 days. Dermabond Prineo system will be applied to the skin for skin closure. | Device | Bundled C-section Wound Closure |
Primary outcome
Canadian Patient Experiences Survey - Inpatient Care + maternity questions
Time frame: Assessed roughly 48-72 hours after C-section delivery
Validated patient reported experience measure (PREM) assessing 1) communication with nurses, 2) communication with doctors, 3) involvement in decision-making and treatment options, 4) information and understanding when leaving the hospital, and 5) overall hospital experience
SCAR-Q Scores
Time frame: Assessed at approximately 6 week follow-up appointment
Validated patient reported outcome measure (PROM) assessing three domains: 1) Scar appearance, 2) Scar Symptoms, and 3) Psychosocial Impact
Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]
Time frame: Assessed at approximately 6 week follow-up appointment
Categories include: no, superficial, deep, organ/space
Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment]
Time frame: Assessed at approximately 6 week follow-up appointment
Self-reported by patient
Antibiotic prescription for treatment of infection [Surgical site infection questionnaire completed at follow-up appointment]
Time frame: Assessed at approximately 6 week follow-up appointment
Self-reported by patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No. Only aggregate data will be shared comparing study arms.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stratafix Suture and DERMABOND PRINEO in people with Cesarean Section; Complications, Wound, Infection (Following Delivery), run by North York General Hospital at 1 site in Canada.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Fan, MHSc (416-756-6000, humanera@nygh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Patient Experiences Survey - Inpatient Care + maternity questions (time frame: Assessed roughly 48-72 hours after C-section delivery). The study lists 5 primary outcomes in all. 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 29 Nov 2024.