Patient Reported Experiences and Outcomes Associated with C-Section Wound Closure Bundle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Canadian Patient Experiences Survey - Inpatient Care + maternity questions
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Canadian Patient Experiences Survey - Inpatient Care + maternity questions
时间窗: 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
时间窗: 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
Diagnosed surgical site infection [Surgical site infection questionnaire completed at follow-up appointment]
时间窗: Assessed at approximately 6 week follow-up appointment
Categories include: no, superficial, deep, organ/space
Readmission to any hospital following birth [Surgical site infection questionnaire completed at follow-up appointment]
时间窗: 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]
时间窗: Assessed at approximately 6 week follow-up appointment
Self-reported by patient
次要结局
未报告次要终点
研究者
Patricia Trbovich
Badeau Family Research Chair in Patient Safety and Quality Improvement
North York General Hospital