Appendicectomy Skin Closure Technique: Changing Paradigms (ASC)

NCT02625987 | Completed Phase 4 DMC

• 1 other identifier: 2015-2301-6
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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,

Conditions

Appendicitis

Keywords

Appendicectomy, wound complications, skin closure

Outcome Measures

Primary Outcomes (1)

• 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.

  1-30 days after surgery

Secondary Outcomes (1)

• Factors associated with appendectomy complications developement

  Previous to surgery and during surgery

Study Arms (2)

Continuous intradermic stitch

EXPERIMENTAL

Closure was did with a continuous intradermic stitch.

Procedure: Continuous intradermic stitch

Separated stitches

SHAM COMPARATOR

Like comparator was used a closure with separated stitches.

Procedure: Separated stitches

Interventions

Continuous intradermic stitch PROCEDURE

Appendectomy wound closure with an intradermic Polyglactina 910 stitch

Also known as: Subdermic closure with an absorbable suture

Continuous intradermic stitch

Separated stitches PROCEDURE

Appendectomy wound closure with a separated stitches.

Also known as: Habitual appendectomy wound closure

Separated stitches

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• María Valeria Jiménez Baez: lead
• Instituto Mexicano del Seguro Social: collaborator

Related Publications (1)

• 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.

  PMID: 27283187 DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Maria Valeria Jimenez Baez, PhD

  Mexican Social Security Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 10, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 27, 2016

Record last verified: 2016-05