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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02625987
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : May 27, 2016
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
María Valeria Jiménez Baez, Coordinación de Investigación en Salud, Mexico

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,

Condition or disease Intervention/treatment Phase
Appendicitis Procedure: Continuous intradermic stitch Procedure: Separated stitches Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Comparison Between Intradermic vs Habitual Skin Closure Technique in Open Appendicectomy.
Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Continuous intradermic stitch
Closure was did with a continuous intradermic stitch.
Procedure: Continuous intradermic stitch
Appendectomy wound closure with an intradermic Polyglactina 910 stitch
Other Name: Subdermic closure with an absorbable suture

Sham Comparator: Separated stitches
Like comparator was used a closure with separated stitches.
Procedure: Separated stitches
Appendectomy wound closure with a separated stitches.
Other Name: Habitual appendectomy wound closure

Primary Outcome Measures :
  1. Decrease in wound complications after appendectomy [ Time Frame: 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.

Secondary Outcome Measures :
  1. Factors associated with appendectomy complications developement [ Time Frame: Previous to surgery and during surgery ]
    General data and surgery data will be analyzed

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02625987

Sponsors and Collaborators
María Valeria Jiménez Baez
Instituto Mexicano del Seguro Social
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Study Director: Maria Valeria Jimenez Baez, PhD Mexican Social Security Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: María Valeria Jiménez Baez, PhD, Coordinación de Investigación en Salud, Mexico Identifier: NCT02625987    
Other Study ID Numbers: 2015-2301-6
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016
Keywords provided by María Valeria Jiménez Baez, Coordinación de Investigación en Salud, Mexico:
Appendicectomy, wound complications, skin closure
Additional relevant MeSH terms:
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Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases