Intraoperative Irrigation of the Surgical Incision With Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil.
详细描述
Patients will be randomized to one of the following intervention groups:
Group 1: intraoperative irrigation/washing of the surgical incision with povidone-iodine (PVP-I); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of povidone-iodine solution (PVP-I). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. " Group 2: intraoperative irrigation/washing of the surgical incision with saline solution (NaCl 0.9%); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of saline solution (NaCl 0.9%). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues.
NOTE: other care routines for participating patients will not be changed by this study. Patients will receive mechanical colon preparation and antibiotic prophylaxis according to routines already in place by the assistant team.
Randomization: the block randomization method will be used (blocks of 4 patients each).
Groups 1 and 2 will be compared with each other regarding the outcomes.
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 (Participant)
盲法说明
Participants will not know what kind of substance will be used during the surgery.
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
- •Patients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the Hospital de Clinicas de Porto Alegre - Division of Coloproctology.
排除标准
- •age under 18;
- •surgery classified as dirty;
- •urgent/emergency surgery;
- •patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ);
- •known allergy to iodine.
研究组 & 干预措施
Povidone-iodine arm
Patients submitted to colorectal resections using Povidone-iodine in the surgical wound.
干预措施: Povidone-iodine (Drug)
Saline solution arm.
Patients submitted to colorectal resections using saline solution in the surgical wound.
干预措施: Saline solution (Drug)
结局指标
主要结局
Surgical site infection
时间窗: 30 days
Surgical site infection within 30 days from the surgical procedure
次要结局
- Intracavitary surgical infection(30 days)