Appendicectomy Skin Closure Technique: Changing Paradigms (ASC)

Appendicitis Clinical Trial

— ASC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625987
• Other study ID #: 2015-2301-6
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2015
• Last updated: May 25, 2016
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Continuous intradermic stitch
Appendectomy wound closure with an intradermic Polyglactina 910 stitch
• Separated stitches
Appendectomy wound closure with a separated stitches.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
María Valeria Jiménez Baez	Instituto Mexicano del Seguro Social

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Factors associated with appendectomy complications developement	General data and surgery data will be analyzed	Previous to surgery and during surgery	Yes