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临床试验/NCT05744284
NCT05744284已完成不适用

It is Time to Change Method of Skin Incision From Scalpel to Electrocautery.

University of Catania1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
281
试验地点
1
主要终点
Cosmetic results

研究概览

简要总结

The use of electrocautery to incise the skin is still debated. Aim of the present study is to contribute at the use of electrocautery for skin incision as safe procedure both for patients and surgeons.

详细描述

All patients observed between 2016 and 2021 at the Department of Surgical Sciences, Organ Transplantation, and Advanced Technologies of University of Catania and submitted to abdominal surgery in which the incision of the skin have been done by electrocautery, have been considered. Sex, age, kind of disease in relation to the organ affected and type of surgical procedure and related incision have been investigated. Patients with diabetes mellitus, coagulation disorders and those submitted to a treatment of steroids and anticoagulant; patients previously operated with scar in the site of the second operations, or with anemia or with active source of infection in any part of the body where excluded from the study.

The ethical approval isn't necessary because is a retrospective study. All patients have express the oral informed consent to participate at this study.

In this retrospective study was analyzed the skin incision that has been classified into laparotomic or laparoscopic, in elective or emergency surgery. The laparotomic included large (large midline as xipho-umbilical or umbilical pubic incision, subcostals or pararectal) and small (small midline no more than 7 cm, inguinal, McBurney) skin incisions. The laparoscopic on the opposite involve incisions from minimum of 1 cm or less for introduction of trocars, and a maximum of 10 cm to extract organ. The subcutaneous layer has been closed using an interrupted suture using Vycril®3-0 on the opposite the skin suture has been done using metallic clips.

All patients have been submitted to general or spinal anesthesia. Antibiotic prophylaxis was done, following the guidelines related to the disease (5). Patients submitted to hernioplasty of laparoscopic cholecystectomy or any procedure in which the literature have reached a consensus any antibiotic treatment including the prophylaxis have not been done (5).

The outcomes considered are wound infections, post-operative pain, healing time, cosmetic results. The post operative pain has been related to the administration of paracetamole 1 gr every 12 hours for the first 3 days. The healing time and cosmetic results have been evaluated both during the hospitalization or in the out patients clinics, after 10 from surgical procedure at moment of ablation of metallic clips, and/or 20 days after the surgical incision with final clinical evaluations of the scar. Finally considering the medical records and operative reports, patients were contacted 6 months later by phone by resident in surgery ask them to evaluate their scar. The patient was asks simple to define their scar as acceptable and consequently patient satisfied or not acceptable so patient not satisfied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • surgical procedure with electrocautery skin incision

排除标准

  • previews scars
  • infections

结局指标

主要结局

Cosmetic results

时间窗: 6 months after surgery

The patient was asked simple to define their scar as acceptable and consequently patient satisfied or not acceptable so patient not satisfied.

Wound infections

时间窗: 10 days

The wound infections were recorded in patients undergoing emergency surgery with laparotomic incisions. As sign of infection were observed fever, pain, hyperaemia and presence of pus.

Post-operative pain

时间窗: 24 hours after procedures

Patients refer pain classified as 1-2 in a numerical rating scale from 0 to 10, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isidoro Di Carlo, MD, PhD, FACS

Professor

University of Catania

研究点 (1)

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