Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)
NCT ID: NCT06614829
Last Updated: 2024-11-29
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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RECRUITING
NA
68 participants
INTERVENTIONAL
2024-10-22
2025-12-31
Brief Summary
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Detailed Description
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Patients in both study arms will complete established questionnaires capturing patient-reported experience measures (PREMS) and patient-reported outcome measures (PROMS).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control
This group would be receiving the standard of care.
No interventions assigned to this group
Bundled C-section Wound Closure
Surgeons in this arm will complete elective C-section wound closure with Stratafix Sutures and the Dermabond PRINEO wound dressing.
Stratafix Suture
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 PRINEO
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.
Interventions
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Stratafix Suture
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 PRINEO
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent.
3. Patients must have internet access and/or a smartphone in order to access the digital platform to complete the study questionnaires
4. Patients must speak and write in English as study questionnaires will only be provided in English
5. Patients must have coverage from the Ontario Health Insurance Plan (OHIP)
Exclusion Criteria
* 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
2. Patients who enroll in the study but have an unplanned emergency C-section
18 Years
FEMALE
No
Sponsors
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Johnson & Johnson
INDUSTRY
North York General Hospital
OTHER
Responsible Party
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Patricia Trbovich
Badeau Family Research Chair in Patient Safety and Quality Improvement
Locations
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North York General Hospital
North York, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0434
Identifier Type: -
Identifier Source: org_study_id