Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives: A Multi-centre Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Surgical Site Infection
研究概览
简要总结
This study evaluates whether specialist negative pressure dressings reduce the risk of wound infections after operations when compared to conservative dressings, and if one negative pressure dressings works better than another. The study will look at patients who have had an open operation on their bowel and the wound closed at the end of the operation.
详细描述
Surgical site infections (SSI) can affect up 41% of patients post-operatively. They are associated with significant healthcare and patient costs, and increased patient morbidity and mortality.
Specialist post operative dressings with negative pressure wound therapy are available, and the WHO do recommended for use in high risk wounds, taking resources into account. However no further recommendations are available.
This study will explore the rate of post-operative wound infections in adult patients undergoing open abdominal surgery on the bowel, and compare the rate of wound infections in these patients in relation to three different dressing types used after their operation. The study aims to determine if any of the dressings used within the study are associated with lower post-operative wound infection rates, and compare the overall costs of using each dressing type, including both direct healthcare costs and societal costs. Finally, it will evaluate participant's quality of life outcomes after open abdominal surgery, specifically relating to their wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency, trauma or elective contaminated abdominal operations within general surgery and/or colorectal surgery
- •Abdominal wounds closed at time of operation and expected to heal by primary intention
- •Patients who have the capacity to consent
- •To include complex abdominal wounds with existing infection where wounds have been closed and expected to heal by primary intention
- •To including graft or flap sites as part of general surgical procedure
- •Patients who are able to complete questionnaires post operatively, either alone or with assistance
排除标准
- •Wounds where an appropriate seal cannot be obtained
- •Wounds left open and expected to heal by secondary intention
- •Patients known to have allergy or sensitivity to dressings being used
- •Patients who lack the capacity to consent
结局指标
主要结局
Surgical Site Infection
时间窗: Up to day 90
The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence
次要结局
- Cause of death(Up to day 90)
- Wound assessments - clinical assessment of presence of wound complication and healing(At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up))
- Length of stay(Up to 90 days)
- Wound dressings - use of(Up to day 30-40)
- Long term follow up - Hernia occurrence(At 1, 3 and 5 years)
- Ninety day mortality rate(Up to day 90)
- Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections(Within 30 days)
- Ninety day readmission rate(Up to day 90)
- Number of additional interventions received by participants due to development of a Surgical Site Infection(Within 30 days)
- Number of adverse reactions to treatments for Surgical Site Infections(Within 30 days)
- Quality of life measures: EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire(At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up))
- Quality of life measures: Wound Quality of Life questionnaires(At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up))
- Post operative complications - other(Within 30 days)
- Quality of life and economic measures: Economic assessment questionnaire(At day 40)