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临床试验/NCT02625987
NCT02625987已完成4 期

Comparison Between Intradermic vs Habitual Skin Closure Technique in Open Appendicectomy.

María Valeria Jiménez Baez0 个研究点目标入组 200 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
200
主要终点
Decrease in wound complications after appendectomy

研究概览

简要总结

To compare the results associated with two different skin closure techniques in open appendectomy. 200 patients were included after acute appendicitis diagnosis in emergency department. They were grouped randomly into two groups: patients who would receive skin closure with skin closure by an unique absorbable intradermic stitch (Group A) and another that would receive a habitual technique consistent in non absorbable separated stitches (Group B). General characteristics like gender, age, body mass index (IMC), comorbidities and allergies were registered. Days of evolution (DOE) until surgery, use of antibiotics previously, complicated or uncomplicated appendicitis, surgery time and wound complications like skin infection, dehiscence, seroma or abscess were registered in each case too,

详细描述

Registration number R2015-2301-6 by Local Committee on Ethics in Health Research and Social Security Mexican Institute, Zone 03 General Hospital. The investigators conduct the study at the Hospital General Regional No. 17 in Cancun, Quintana Roo. México. At time in which General Surgery Department determined acute appendicitis diagnosis and prophylaxis antibiotics administered with 3rd generation cephalosporin and Metronidazole, patients receive information about the study and treatment options and informed consent were signed. After this, patients were randomly assigned to one of two study groups. Group A receives a skin closure with a unique absorbable suture intradermal stitch. Group B receives a skin closure with habitual technique, consistent in separated stitch of a non-absorbable suture. The surgical and skin closure techniques were standardized among eight surgeons who participate in the study.

Acute appendicitis diagnosis was established by clinical history, physical exam and laboratory test including blood count, glucose, urea, creatinine, general urinary exam and clothing times. An Alvarado scale >7 points or the surgeon opinion was diagnostic of appendicitis. General information about the patients were recorded like gender, age, body mass index (IMC), comorbidities and allergies were registered. Clinical history information like DOE and previous antibiotics use were registered too.

After explanation of the diagnosis and treatment options, the patients were informed about this study, the objectives, implications, possible outcomes and complications. The patients or legal tutor of the patients refer to understand the possible risk and consequences and if they accept to be included in the study an informed consent was signed.

One hour before skin incision a prophylaxis dose of a 3rd Generation Cephalosporin (Cefotaxime) and Metronidazole were administered. According to a randomized list patients were assigned to one of the two study groups previous to his/her skin incision. The surgical and skin closure technique were standardized and verified by the protocol author previous to the development of any appendectomy by the eight surgeons included in the study.

A Rochy-Davis incision was performed in all cases and aspiration of purulent liquid when required. Stump management with Halsted or Pouchet technique was done. Abdominal cavity was cleaned only with gauze pads, no drain were placed. After aponeurosis closure with Polyglactina 910 #1 continuous point, wound lavage with NaCl 0.9% solution was performed. Dermis was closed with Polyglactina 910 #3-0. In Group A Polyglactina 910 # 3-0 intradermic continuous point was done. In Group B skin closure with Nylon #3-0 separated stitches was achieved.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Both gender
  • Appendicitis diagnosis
  • Informed consent signed
  • 0-60 age year old
  • surgical confirmation of acute appendicitis
  • Antibiotic prophylaxis

排除标准

  • Appendicitis diagnosis in patients >60 years old
  • No antibiotic prophylaxis
  • No informed consent signed

结局指标

主要结局

Decrease in wound complications after appendectomy

时间窗: 1-30 days after surgery

Complication like wound seroma, infection, dehiscence or abscess would be registered in each one of the two groups and the incidence compared between them to stablish which one is the best option.

次要结局

  • Factors associated with appendectomy complications developement(Previous to surgery and during surgery)

研究者

发起方
María Valeria Jiménez Baez
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

María Valeria Jiménez Baez

PhD

Coordinación de Investigación en Salud, Mexico

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