Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 876
- 试验地点
- 8
- 主要终点
- The incidence of post-CS wound infection in each study group
研究概览
简要总结
The purpose of this study is to examine whether obese women (BMI >= 30) who give birth by caesarean section have a reduced incidence of wound infection and dehiscence when incisional Negative Pressure Wound Therapy is applied prophylactically following caesarean section.
详细描述
This study is a non-blinded randomised controlled trial and a concurrent Health Economic Evaluation. The study examines the effect on wound healing using incisional Negative Pressure Wound Therapy (iNPWT) compared with standard postoperative dressings in women with a BMI >= 30, who has a Caesarean Section (CS). We expect to find a lower frequency of wound complications when using iNPWT directly on primary suturing compared to standard postoperative dressings in this high-risk subpopulation.
Women, who have given informed consent, will be randomised to either intervention or control group via a computer-generated randomisation program. Elective and emergency CS will be stratified to ensure roughly equal numbers in each category of CS in each arm of the study and permit valid separate and pooled analysis. The analysis will be carried out on an intention to treat basis.
The iNPWT or standard postoperative dressings will be applied in theatre immediately following the operation. In the intervention group the therapy will be left in situ for five days corresponding to the date of removal of stitches. In the control group the dressing will be left in situ for at least 24 hours as standard procedure. Women, who do not wish to participate, will be asked for permission to use their data in the analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥ 18 year
- •Women who can read and understand Danish
- •pregestational BMI ≥ 30 kg/m2
排除标准
- 未提供
研究组 & 干预措施
iNPWT
Negative Pressure Wound Therapy (NPWT) is a mechanical wound care treatment using controlled sub-atmospheric pressure to assist and accelerate wound healing. Incisional Negative Pressure Wound Therapy (iNPWT) is a new NPWT devices, which can be used over clean closed surgical incisions. The device behaves in a similar fashion to existing conventional NPWT devices, i.e. transmission of negative pressure levels at the wound bed, tissue contraction and establishing a characteristic pattern of peri-wound blood flow and that it reduces and normalises tissue stresses at the incision
干预措施: iNPWT (Device)
Standard wound dressing
The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions.
干预措施: Standard postoperative wound dressing (Other)
结局指标
主要结局
The incidence of post-CS wound infection in each study group
时间窗: Within the first 30 days after surgery
Wound infection requiring antibiotic treatment To be able to collect information about symptoms of infection after discharge a self-administered questionnaire will be sent to all participants within 30 days post-CS. Furthermore data on postoperative infections, recorded by diagnoses codes or surgical procedures, will be obtained from the Danish National Patient Registry
次要结局
- Length of the primary and any secondary hospitalization(Within the first 30 days after Caesarean Section)
- Readmissions to hospital/contact to the general practitioner on suspicion of infection following caesarean section(Within the first 30 days after Caesarean Section)
- Number of Participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability(Within the first 30 days after Caesarean Section)
- Antibiotic treatment on suspicion of infection after Caesarean Section(Within the first 30 days after Caesarean Section)
- The cosmetic outcome as a measure of satisfaction(A 6 and 12 months follow-up)
- Other wound complications after caesarean section(Within the first 30 days after Caesarean Section)
研究者
Nana Hyldig
PhD Student
Odense University Hospital