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Appendicectomy Skin Closure Technique: Changing Paradigms (ASC) (ASC)

Primary Purpose

Appendicitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Continuous intradermic stitch
Separated stitches
Sponsored by
María Valeria Jiménez Baez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Appendicitis focused on measuring Appendicectomy, wound complications, skin closure

Eligibility Criteria

1 Year - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Continuous intradermic stitch

    Separated stitches

    Arm Description

    Closure was did with a continuous intradermic stitch.

    Like comparator was used a closure with separated stitches.

    Outcomes

    Primary Outcome Measures

    Decrease in wound complications after appendectomy
    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.

    Secondary Outcome Measures

    Factors associated with appendectomy complications developement
    General data and surgery data will be analyzed

    Full Information

    First Posted
    December 7, 2015
    Last Updated
    May 25, 2016
    Sponsor
    María Valeria Jiménez Baez
    Collaborators
    Instituto Mexicano del Seguro Social
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02625987
    Brief Title
    Appendicectomy Skin Closure Technique: Changing Paradigms (ASC)
    Acronym
    ASC
    Official Title
    Comparison Between Intradermic vs Habitual Skin Closure Technique in Open Appendicectomy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    María Valeria Jiménez Baez
    Collaborators
    Instituto Mexicano del Seguro Social

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appendicitis
    Keywords
    Appendicectomy, wound complications, skin closure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous intradermic stitch
    Arm Type
    Experimental
    Arm Description
    Closure was did with a continuous intradermic stitch.
    Arm Title
    Separated stitches
    Arm Type
    Sham Comparator
    Arm Description
    Like comparator was used a closure with separated stitches.
    Intervention Type
    Procedure
    Intervention Name(s)
    Continuous intradermic stitch
    Other Intervention Name(s)
    Subdermic closure with an absorbable suture
    Intervention Description
    Appendectomy wound closure with an intradermic Polyglactina 910 stitch
    Intervention Type
    Procedure
    Intervention Name(s)
    Separated stitches
    Other Intervention Name(s)
    Habitual appendectomy wound closure
    Intervention Description
    Appendectomy wound closure with a separated stitches.
    Primary Outcome Measure Information:
    Title
    Decrease in wound complications after appendectomy
    Description
    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.
    Time Frame
    1-30 days after surgery
    Secondary Outcome Measure Information:
    Title
    Factors associated with appendectomy complications developement
    Description
    General data and surgery data will be analyzed
    Time Frame
    Previous to surgery and during surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Both gender Appendicitis diagnosis Informed consent signed 0-60 age year old surgical confirmation of acute appendicitis Antibiotic prophylaxis Exclusion Criteria: Appendicitis diagnosis in patients >60 years old No antibiotic prophylaxis No informed consent signed
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Valeria Jimenez Baez, PhD
    Organizational Affiliation
    Mexican Social Security Institute
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27283187
    Citation
    Andrade LA, Munoz FY, Baez MV, Collazos SS, de Los Angeles Martinez Ferretiz M, Ruiz B, Montes O, Woolf S, Noriega JG, Aparicio UM, Gonzalez IG. Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC). World J Surg. 2016 Nov;40(11):2603-2610. doi: 10.1007/s00268-016-3607-x.
    Results Reference
    derived

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    Appendicectomy Skin Closure Technique: Changing Paradigms (ASC)

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