Randomized Controlled Trial of the Effectiveness of Bra Application in Women as a Device for Prevention of Surgical Wound Dehiscence in the Post-operative Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Dehiscence
研究概览
简要总结
The aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.
详细描述
Background: it is known that the size and support of the breasts are a specific problem in post-operative women of cardiac surgery by means of medium sternotomy. There is little evidence of the therapeutic action of the bra as a measure to prevent dehiscence of the surgical wound.
Aim: To assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.
Methods: Randomised clinical trial; post-test control group in women undergoing cardiac surgery by mean sternotomy. Groups: application of post-surgical or non-surgical breast bra. Endpoint: incidence of dehiscence. Other variables: sociodemographic, signs of infection, pain, related to assessment of the wound on admission. Assessment of the surgical wound daily, at discharge, at month, 3 months and 6 months post discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Over 18 years
- •Cardiac surgery intervention in the Germans Trias i Pujol University Hospital with non-critical preoperative
- •Surgical intervention performed throughout medium sternotomy
排除标准
- •More than 72 hours admitted in an intensive care unit after surgery
- •Cognitive impairment or severe physical disability
- •Mastectomy
- •External wound occlusion with Opsite® fixative absorbent dressing
- •Emergency surgery
结局指标
主要结局
Dehiscence
时间窗: Baseline (admission) to 6 months after hospital discharge
Dehiscence in the surgical wound. Criteria defined according to an established scale for the assessment of surgical wounds contemplated in the GacelaCare® computer system used in Germans Trias i Pujol University Hospital. Values may be "Yes" or "No".
次要结局
未报告次要终点