Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Satisfaction and QoL Questionnaire
研究概览
简要总结
This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).
详细描述
Subjects requiring cesarean delivery and without exclusion criteria will be informed by the obstetrical team about the study and asked for permission to contact the study personnel. Written informed consent will be obtained by person-to-person contact. The research staff will be responsible for the informed consent.
Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation:
- Standard Wound Care: Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
- CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions (Appendix A) intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
The remainder of the subjects' care will be similar for both arms and will follow current standard clinical practice at the University of Texas Medical Branch (UTMB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Data analysis will be blinded to assignment including the principal investigator.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-50 years of age.
- •Women ≥ 24 weeks' viable gestation.
- •To undergo cesarean delivery.
- •Admission BMI ≥ 35.
排除标准
- •Patient unwilling or unable to provide consent.
- •No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
- •Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other.
- •Decision not to have skin closure (e.g. secondary wound closure, mesh closure).
- •Current skin infection.
- •Coagulopathy.
- •High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
- •Known allergy to CHG.
- •Incarcerated individuals.
- •Chorioamnionitis.
- •Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
结局指标
主要结局
Satisfaction and QoL Questionnaire
时间窗: Postpartum wound care visit (up to 10days postpartum)
We will be assessing through a survey patient satisfaction concerning dressing received and assess the quality of life while receiving either intervention (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.
次要结局
- Number of Participants That Resulted in Maternal Death(4 days postpartum)
- Provider Satisfaction(Postpartum wound care visit (up to 10days postpartum))
- Number of Participants With Composite Wound Complication(30 days postpartum)
- Number of Participants With Wound Breakdown(30 days postpartum)
- Number of Participants With Puerperal Fever(4 days postpartum)