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Recruiting NCT06614829

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

No phase Interventional Cesarean Section; Complications, Wound, Infection (Following Delivery)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stratafix Suture, DERMABOND PRINEO.
Who it may be relevant to
Registry conditions: Cesarean Section; Complications, Wound, Infection (Following Delivery). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle

Overview

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

  • Device 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.
  • Device 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.

Primary outcome measures

  • Canadian Patient Experiences Survey - Inpatient Care + maternity questions [Time frame: Assessed roughly 48-72 hours after C-section delivery]
  • SCAR-Q Scores [Time frame: Assessed at approximately 6 week follow-up appointment]
  • Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment] [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] [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] [Time frame: Assessed at approximately 6 week follow-up appointment]

Eligibility criteria

Inclusion criteria

  • 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
  • Patients must have coverage from the Ontario Health Insurance Plan (OHIP)

Exclusion criteria

  • 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
  • Patients who enroll in the study but have an unplanned emergency C-section

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 1 center
  • North York General Hospital — North York

Identifiers

NCT: NCT06614829 · 0434

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗