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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratafix Suture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | Assessed at approximately 6 week follow-up appointment |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Fan, MHSc | Contact | 416-756-6000 | humanera@nygh.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North York General Hospital | Recruiting | North York | Ontario | M2K1E1 | Canada |
Only aggregate data will be shared comparing study arms.
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Parallel between group study
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| DERMABOND PRINEO | Device | 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. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007239 | Infections |
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