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临床试验/NCT01891006
NCT01891006已完成不适用

Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
The frequency of re-rupture in each study group

研究概览

简要总结

The purpose of this study is to examine whether Negative Pressure Wound Therapy is an effective wound treatment compared to conventional wound treatment in the period of time from reoperation to re-suturing in women having surgical wound rupture after Caesarean Section.

详细描述

This study is a non-blinded randomized controlled trial and a concurrent Health Economic. The study examines the effect on wound healing using NPWT compared with conventional wound treatment in women, who experience spontaneous dehiscence or where a surgeon deliberately opens the wound after Caesarean Section (CS).

Women, who have given informed consent, will be randomized to either intervention or control group via a computer-generated randomization program. It is not possible to blind either participants or therapists. The analysis will be carried out on an intention to treat basis.

Women with post-CS wound infection will be hospitalized and the wound will be reopened and cleaned under general anaesthesia. In the intervention group women will be treated with NPWT. The change of wound dressing on the second day takes place in the obstetrical or plastic surgery ward. On the fourth day, the NPWT material will be removed and the wound evaluated before re-suturing. In the control group the wound will be treated with a hydrofiber or alginate dressing. Changes of wound dressing will take place on the second and fourth days as in the intervention group. In both groups, when the wound is evaluated on the second and fourth day, it will be described and measured (depth, width, length). After four days of treatment, the wound will be re-sutured in both groups. It is expected that some wounds are not suitable for re-suturing on the fourth day. If a woman does not want to participate, she will receive the conventional treatment, which corresponds to the treatment in the control group. 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
Treatment
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

入选标准

  • Age ≥ 18 year
  • Women, who can read and understand Danish

排除标准

  • Serious illness requiring medical treatment, such as cancer
  • Stillborn child
  • If the fascia is ruptured

结局指标

主要结局

The frequency of re-rupture in each study group

时间窗: Within the first 30 days after surgery

次要结局

  • Length of hospitalization(Within the first 30 days after Caesarean Section)
  • Readmission to hospital due to wound complications after the re-operation(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)
  • The cosmetic outcome as a measure of satisfaction(A 6 and 12 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nana Hyldig

PhD Student

Odense University Hospital

研究点 (2)

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