It is Time to Change Method of Skin Incision From Scalpel to Electrocautery.
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
- 否
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
Isidoro Di Carlo, MD, PhD, FACS
Professor
University of Catania
