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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
68
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™ 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.
North York General Hospital
North York, Ontario, Canada
RECRUITINGCanadian 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessed at approximately 6 week follow-up appointment
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