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NCT Number: NCT06614829

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

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.

Recruiting

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Key information

Conditions

Cesarean Section; Complications, Wound, Infection (Following Delivery) Infections Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

North York General Hospital

North York, Ontario, M2K1E1, Canada

Location status: Recruiting

Location contact

Mark Fan

CONTACT

[email protected]

416-756-6000

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Canadian Patient Experiences Survey - Inpatient Care + maternity questions

    Time frame: 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

  2. SCAR-Q Scores

    Time frame: 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

  3. Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]

    Time frame: Assessed at approximately 6 week follow-up appointment

    Categories include: no, superficial, deep, organ/space

  4. 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

    Self-reported by patient

  5. 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

    Self-reported by patient

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Fan, MHSc

CONTACT

[email protected]

416-756-6000

Sponsors and collaborators

Lead sponsor

North York General Hospital

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Acronym: CS-PREO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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