Application of Hyperoxygenated Fatty Acids in a Surgical Wound of the Umbilical Trocar After Laparoscopic Cholecystectomy With Placement of a Prosthesis in Patients With Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
TITLE:
Application of hyperoxygenated fatty acids (PrevOmega) in a surgical wound of the umbilical trocar after laparoscopic cholecystectomy with placement of prostheses in patients with risk factors.
OBJECTIVE: This study aimed to evaluate the effect of topical application of hyperoxygenated fatty acids (AGHO), PrevOmega, at the umbilical trocar level after laparoscopic cholecystectomy with prosthesis placement, regarding its non-application, on the infection rate. of the surgical site (ISQ) and eventration of the trocar orifice (EOT), in patients with risk factors for ISQ AND EOT.
METHODS: A prospective, double-blind, randomized study was performed in patients operated on for scheduled cholelithiasis, who also had any of the following risk factors that increase the appearance of SSI or OOT: BMI> 30kg / m2, Diabetes Mellitus, age> 65 years and Chronic Obstructive Pulmonary Disease. Group A was administered physiological saline (SSF) at the umbilical trocar level at the end of the intervention versus the administration of PrevOmega to group B. The study was carried out between January 2018 and January 2020 and is registered in the European Database of Clinical Trials with the EudraCT Code: 2018-002260-67.
详细描述
This study aimed to evaluate the effect of topical application of hyperoxygenated fatty acids (AGHO), PrevOmega, at the umbilical trocar level after laparoscopic cholecystectomy with prosthesis placement, regarding its non-application, on the infection rate. of the surgical site (ISQ) and eventration of the trocar orifice (EOT), in patients with risk factors for ISQ AND EOT.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ages between 18 and 90 years who underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and who also presented any of the following risk factors for SSI or EOT were included:
- •Obesity with body mass index (BMI)> 30kg / m2
- •Diabetes Mellitus (insulin dependent or oral antidiabetic takers)
- •Age (> 65 years)
- •Chronic Obstructive Pulmonary Disease (COPD in treatment with inhalers).
排除标准
- •Non-compliance with the inclusion criteria
- •Conversion to laparotomy during the intervention
- •Non-acceptance by the patient to participate in the study,
- •Loss to follow-up.
研究组 & 干预措施
Group A. Physiological saline.
The surgical procedure in group A consisted of the placement of a 6.4cm diameter circular prosthesis (BARD Hernia Patch) at the intra-abdominal level. Subsequently, the liquid contained in the 10 ml opaque vial was administered (Ecolav Physiological Washing Serum 0.9%, (SSF).
干预措施: Physiological saline (Procedure)
Group B. Solution hyperoxygenated fatty acids
The surgical procedure in group B consisted of the placement of a 6.4cm diameter circular prosthesis (BARD Hernia Patch) at the intra-abdominal level. Subsequently, the liquid contained in the 10 ml opaque vial (AGHO solution) was administered according to randomization.
干预措施: PrevOmega (Procedure)
结局指标
主要结局
Surgical site infection
时间窗: 1 year
Surgical site infection rate in patients with risk factors for infection and eventration after laparoscopic cholecystectomy
次要结局
- Trocar hole eventration(1 year)
研究者
Marta Bellón
Physician
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana