PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI
研究概览
简要总结
The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery
详细描述
Is a clinical trial phase IV prospective, blind, controlled and random allocation of treatment with the active principle of amoxicillin 1000mg and 200mg Clavulanic acid, administered topically and dissolved in 500 ml of saline 0.9%. To demonstrate its effectiveness in the surgical wound infection prophylaxis be used in contaminated surgery and be compared its effectiveness with the topical administration of normal saline only.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
In the operating room area we will keep a notebook with the random number sheet and a box with the numbered envelopes and containing the treatment to follow: physiological saline alone or physiological saline with antibiotic. At the end of the surgery and before closing the abdominal wall, it is definitively informed to the nurse whether or not to recruit them, a case number is assigned chronologically and in the random number sheet corresponds to an envelope containing one of the two treatments. Dilution is performed with 10cc of physiological saline solution with or without antibiotic in the outside of the operating room and then it is incorporated into the 500cc bottle of physiological saline once opened in a sterile way. We used according to the usual protocol.
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 over 18 years of age.
- •Patients who require urgent surgical intervention and who come from the emergency service
- •Patients affected by complicated intra-abdominal infection with peritonitis of more than one abdominal compartment or intra-abdominal abscess requiring open surgical intervention.
排除标准
- •Women patients with positive pregnancy test.
- •Patients with primary peritonitis and liver cirrhosis.
- •Patients who have received antibiotic treatment during the 72 hours prior to the surgical intervention (except that administered to UCIES as a treatment dose of the same process)
- •Patients allergic to the antibiotic used in the study.
- •Patients who have undergone a surgical procedure of recently opened abdomen (up to 30 days before surgery), a prosthesis of synthetic material (mesh) or to which the surgical wound can not be closed according to the surgeon's criteria.
- •Patients with an unfavorable life prognosis (ASA 5).
研究组 & 干预措施
amoxicillin clavulanate
1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.
干预措施: Amoxicillin Clavulanate (Drug)
amoxicillin clavulanate
1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.
干预措施: Physiological Saline (Drug)
Physiological Saline
500 milliliters of 0.9% Physiological Serum.
干预措施: Physiological Saline (Drug)
结局指标
主要结局
Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI
时间窗: 30 days
Evaluation of the effect of topical antibiòtic ( Amoxicillin 1000mg and 200mg of Clavulanic acid dissolved in 500 milliliters of 0.9% Physiological Serum ) prophylaxis on the incidence of Surgical Site Infection in surgery due to emergency intra-abdominal infection
次要结局
- reduction of hospital stay(30 days)
- Bacterial charge(30 days)
- Bacterial resistance(30 days)
研究者
Miquel Casal Rossell
General Surgeon
Universitat Internacional de Catalunya