Appendicectomy Skin Closure Technique: Changing Paradigms (ASC)
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 4

Summary: 
      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,
    

Detailed description: 
      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.

      Liquid diet was ingested 8 hours after surgery and progressed to normal if tolerated. In
      cases of complicated appendicitis antibiotics were continued four to five days and for
      uncomplicated appendicitis only by 2 days or until inflammatory systemic response signs were
      absent. When diet was tolerated and systemic response signs were absent discharge was
      accomplished.

      Surgery incision was evaluated daily until discharge and in extern consult at 7 and 30 days
      after surgery. In case of group B stitches removal were done at 10 days after surgery.

      Days of evolution (DOE) previous to appendicitis diagnose, 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.

      Database was performed and the statistical program SPSS version 22.0 for Mac IOS 7.0 was used
      to perform statistical data analysis. Complications, surgical and general characteristics
      were registered and compared between the groups using X2 test. A multivariate analysis was
      performed for independent variables and the possible association with complications.
    

Intervention name(s): Continuous intradermic stitch; Separated stitches
Intervention type(s): Procedure; Procedure
Intervention description(s): Appendectomy wound closure with an intradermic Polyglactina 910 stitch; Appendectomy wound closure with a separated stitches.
Other intervention name(s): Subdermic closure with an absorbable suture; Habitual appendectomy wound closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Appendicectomy, wound complications, skin closure