Cesarean Section; Complications, Wound, Infection (Following Delivery)
Conditions
Brief 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.
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).
Interventions
DEVICEStratafix 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.
DEVICEDERMABOND 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.
Sponsors
Johnson & Johnson
North York General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Parallel between group study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must be 18 years of age or older at time of recruitment 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
1. 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 2. Patients who enroll in the study but have an unplanned emergency C-section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment] | Assessed at approximately 6 week follow-up appointment | Categories include: no, superficial, deep, organ/space |
| Canadian Patient Experiences Survey - Inpatient Care + maternity questions | 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 | 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 |
| Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment] | 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] | Assessed at approximately 6 week follow-up appointment | Self-reported by patient |
Countries
Canada
Contacts
Primary ContactMark Fan, MHSc
Outcome results
None listed