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
About this trial
This is an interventional prevention trial for Appendicitis focused on measuring Appendicectomy, wound complications, skin closure
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
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
NCT ID
NCT02625987
First Posted
December 7, 2015
Last Updated
May 25, 2016
Sponsor
María Valeria Jiménez Baez
Collaborators
Instituto Mexicano del Seguro Social
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
Learn more about this trial
Appendicectomy Skin Closure Technique: Changing Paradigms (ASC)
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