Medela INVIA Motion NPWT System for Prophylactic Use on Surgical Incision After Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient Satisfaction With Aesthetic Appearance: Scale
研究概览
简要总结
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.
详细描述
This study will be a two center case series of women undergoing caesarean delivery conducted at two medical centers in Indianapolis, Indiana.
All patients meeting inclusion criteria will be included. All enrolled patients will receive the Medela INVIA Motion prophylactic NPWT device.
Visit A: Interventional Procedure All enrolled patients will receive the Medela INVIA Motion device placed by the patient's surgeon after the skin is closed with subcuticular suture or staples. Research staff and clinicians (labor & delivery and postpartum nurses, OR technicians, physicians, etc.) involved in the study will receive formal training on how to place and remove the prophylactic NPWT device.
Visit B: Post Procedure until Discharge Patients will be monitored daily while in the hospital by clinical staff and/or research staff for complications.
The negative pressure wound therapy dressing will be removed on the day of discharge. If the patient remains hospitalized for more than 7 days, the dressing will be removed on postoperative day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled/non-labor or unscheduled/labor cesarean delivery
- •Gestational age greater than or equal to 23 weeks
排除标准
- •Unwilling or unable to provide consent
- •Non-availability for postoperative follow-up
- •Contraindication to NPWT
结局指标
主要结局
Patient Satisfaction With Aesthetic Appearance: Scale
时间窗: At postoperative day 30 (+/- 2 days)
Patient satisfaction with aesthetic appearance (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
Pain Scores: Discharge Time Frame
时间窗: At post-operative day 3 (+/- 1 days)
Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
Patient Satisfaction: Scores Discharge Time Frame
时间窗: At postoperative day 3 (+/- 1 days)
Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
Pain Scores: Scores Postpartum Day 30
时间窗: At postoperative day 30 (+/- 2 days)
Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
Patient Satisfaction: Scores Postpartum Day 30
时间窗: At postoperative day 30 (+/- 2 days)
Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
次要结局
- Wound Separation; Proportion of Incidence(4-6 Weeks Postpartum)
- Allergic Reaction; Safety Outcomes(4-6 Weeks Postpartum)
- Wound Bleeding; Safety Outcomes(4-6 Weeks Postpartum)
- Antibiotics Prescribed for Presumed SSI; Proportion of Incidence(4-6 Weeks Postpartum)
- Skin Blistering; Safety Outcomes(4-6 Weeks Postpartum)
- Wound Infection; Proportion of Incidence(4-6 Weeks Postpartum)
- Seroma; Proportion of Incidence(4-6 Weeks Postpartum)
研究者
David Haas
Professor of Obstetrics and Gynecology
Indiana University School of Medicine