Skin Incision Study - Closure of Skin Incisions in Gynecological Cancer Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication
研究概览
简要总结
The Skin Incision Study evaluates the efficacy of skin closure methods: skin staples and subcuticular sutures at 6 weeks and at 3 months following the operation by measuring cosmesis and pain.
详细描述
The Surgical Skin Incisions (SSI) is an investigator initiated, randomized, prospective (pilot) study comparing methods of skin closure following gynecological cancer surgery to evaluate:
- cosmesis;
- pain;
- adverse events.
The two most common methods of skin incision closure are staples or subcuticular sutures. Adverse events to surgical incisions represent major and significant burdens to patients and the health care system; however, no data is available comparing methods of skin closure. Surgeons have traditionally had to use personal belief rather than data or evidence to choose the method of skin incision closure. This study evaluates three types of skin closure methods:
- Skin staples;
- Monocryl subcuticular sutures;
- Caprosyn subcuticular sutures.
The objective of this trial is to evaluate the efficacy of sutures and staples at 6 weeks and at 3 months following the operation by measuring cosmesis and pain. These are assessed by both the patient and the surgeon independently using linear analogue scales and by collecting information on analgesic medications taken by the patient. The safety of the staples and sutures will be expressed by the incidence of adverse events following surgery. Post-operative events such as wound infection, other wound complications, grade of inflammation, hemorrhage and other complications will be graded according to the Common Toxicity Criteria (CTC version 3) and recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Public patients at RBWH and at the Mater Public Hospital booked for elective surgery (laparotomy)
- •Surgery for suspected or proven gynecological cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patient compliance and geographic proximity that allow adequate follow-up
- •Signed written informed consent
- •Females >=18 years of age
排除标准
- •Unplanned laparotomy
- •Laparoscopic procedures
- •Unwillingness of the patient to participate in the trial
- •Non-compliance of participant
- •Unavailability for follow-up
- •Patients who are unable or unwilling to give informed consent
结局指标
主要结局
Efficacy of the device as measured by cosmesis, pain and requirement for analgesic and antibiotic medication
时间窗: 6 weeks after surgery
次要结局
- To evaluate the wound healing process (normal or delayed), cosmesis and pain, requirement for surgical or medical intervention (analgesic and antibiotic medication)(3 months after surgery)
- Safety of the device as expressed in the incidence of adverse events following surgery(6 weeks after surgery)