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临床试验/NCT05896462
NCT05896462已完成不适用

The Effect of Skin Antisepsis After Primary Skin Closure on the Incidence of Surgical Site Infection After Abdominal Surgery for Sepsis: a Preliminary Report of a Randomized Controlled Trial

Ikechukwu Bartholomew Ulasi2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2019年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
SSI (Surgical Site Infection)

研究概览

简要总结

The benefits of pre-incision skin antisepsis is well established. However, the role of skin antisepsis after skin closure in abdominal surgery for sepsis is not well reported. This study examined whether the use of skin antisepsis after closing the skin during a surgery for an infection within the abdomen would have an effect on wound infection in the post-operative period. The patients - aged 18 years and above - were categorised into two groups: the first had antisepsis with povidone iodine-soaked gauze while the second group of patients had their wound only dressed with a dry sterile gauze. Both groups were then compared for the occurrence of surgical site infection and other post-operative outcomes. The null hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have no effect on the incidence of post-operative Surgical Site Infection while the alternative hypothesis was that intra-operative skin antisepsis after skin closure following abdominal surgeries would have an effect on the incidence of post-operative Surgical Site Infection.

详细描述

The beneficial role of this pre-operative skin preparation has been fully established in several studies, persisting debate being essentially limited to which agent or combination of agents provides superior antiseptic benefit.

However, following skin closure after abdominal surgery, and cleaning the wound edges and surrounding skin of blood and other tissue fluid with a soapy antiseptic agent, some surgeons clean the apposed skin edge with an antiseptic solution, either isopropyl alcohol (more commonly) or povidone-iodine, before application of sterile dressings. The effects of this practice after skin closure in terms of post-operative wound outcome remains to be established. This was a prospective randomized controlled study conducted at the University College Hospital Ibadan, Nigeria. Study participants were recruited from adult patients presenting through the Surgery Out-Patient (SOP) department, Emergency departments and non-surgical wards of University College Hospital, Ibadan. Assuming a standard normal deviate at 5% type I error of 1.96, power of 80%, an SSI prevalence of 38.1% in the control group10 with 15% degree of precision, a total sample size of 84 patients were obtained, having considered an attrition rate of 5%. This preliminary report is based on 37 patients recruited so far.

. Study participants were randomized into 2 groups: povidone iodine (PI) & Control (C) groups using blocked sequence randomization. Consecutive adult surgical patients (aged 18 years and above) booked to have abdominal surgery for sepsis were prospectively enrolled in turns into the two study groups.

Shaving of abdominal hair was done for all patients just before the surgery using a surgical blade. They were given a single dose each of intravenous ceftriaxone (1g; Zonon; Sanofi;) and metronidazole (500mg; Metrone; Aventra) at the induction of anaesthesia. After surgery, patients with contaminated wounds were given intravenous ceftriaxone and metronidazole, discontinued after 24hours post-operatively. Patients with dirty wounds received therapeutic doses of post-operative antibiotics intravenously (iv ceftriaxone 1 g 12hourly and iv metronidazole 500mg 8hourly) for 10-14days. This was converted to oral antibiotics (cefpodoxime 200mg 12hourly and metronidazole 500mg 8hourly) once oral intake was established.

Skin preparation was done as follows: scrubbing of the operation site twice over 3-5 minutes using savlon (0.3% chlorhexidine-gluconate in alcohol + 3% cetrimide) was followed by drying of the skin with a sterile gauze. The operation site was painted with 10% povidone iodine followed by 70% isopropyl alcohol before draping. A midline incision that provides adequate exposure was made using a scalpel and deepened using monopolar diathermy. Upon gaining peritoneal access, a wound swab was taken from the focus of peritoneal contamination/sepsis. The surgical procedures relevant for each case was carried out.

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, 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

入选标准

  • All patients requiring laparotomy for sepsis aged 18 years and above

排除标准

  • All cases of clean and clean-contaminated abdominal surgeries

结局指标

主要结局

SSI (Surgical Site Infection)

时间窗: From day 3 post-operatively up to 28 days post-operatively

Incidence of surgical site infection

次要结局

  • LOS (Length of Stay)(From day 1 post-operatively up to the day of discharge)

研究者

发起方
Ikechukwu Bartholomew Ulasi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ikechukwu Bartholomew Ulasi

Principal investigator

University College Hospital, Ibadan

研究点 (2)

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