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Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)

ConditionCesarean Section; Complications, Wound, Infection (Following Delivery)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorth York General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Bundled C-section Wound ClosureActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Assessed roughly 48-72 hours after C-section delivery
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

North York General HospitalRecruitingM2K1E1, North York, OntarioCanadaCanada

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

North York General Hospital

Lead sponsor

Johnson & Johnson

Collaborator

Source ClinicalTrials.gov
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