The current study aimed to comparing subcuticular and transdermal appendectomy wound stitching methods in terms of pain, infection rate, and patients’ satisfaction to introduce the more suitable method.
Design
Patients randomly assigned into two groups of randomized clinical trials with a parallel design and 1:1 ratio. The sample size was 210 subjects based on previous studies. The subjects were studied and followed up in two groups of 105 patients; the first group as the subcuticular method and the second group as the transdermal method.
Settings and conduct
In Shahid Modarres Hospital of Tehran, after obtaining informed consent, patients underwent the appendectomy and then the incision line was stitched using subcuticular and transdermal method in two groups. Then they were examined and compared.
Participants/Inclusion and exclusion criteria
The inclusion criteria were the patients with appendicitis symptoms referred to the Emergency Department of Shahid Modarres Hospital and diagnosed with appendicitis based on their medical history and physical examinations. The exclusion criteria were age under 10 or above 45 years, normal appendix, advanced or perforated appendicitis, delayed appendectomy, diabetes, patients on chemotherapy, the ones receiving corticosteroids or antifungal drugs, immunodeficiency diseases, history of radiotherapy.
Intervention groups
In the first group, the subcuticular method was used to repair the surgical wound and in the second group, the transdermal method was employed.
Main outcome variables
Local infection; Wound dehiscence ; Level of pain ; Scar thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161217031440N1
Registration date:2018-09-27, 1397/07/05
Registration timing:retrospective
Last update:2018-09-27, 1397/07/05
Update count:0
Registration date
2018-09-27, 1397/07/05
Registrant information
Name
Barmak Gholizadeh
Name of organization / entity
Shahid beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 6403
Email address
b_gholizadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-03-21, 1397/01/01
Trial completion date
empty
Scientific title
Comparison of Subcuticular and Transdermal Appendectomy Repairs in appendectomy patients; a Randomized Clinical Trial
Public title
Comparison of Subcuticular and Transdermal Appendectomy Repairs; a Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria were the patients with appendicitis symptoms referred to the Emergency Department of Shahid Modarres Hospital and diagnosed with appendicitis based on their medical history and physical examinations.
Exclusion criteria:
Age under 10 or above 45 years
Normal appendix
Advanced or perforated appendicitis
Delayed appendectomy
Diabetes
Patients on chemotherapy
The ones receiving corticosteroids or antifungal drugs
Immunodeficiency diseases
History of radiotherapy
Age
From 10 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
251
Actual sample size reached:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by random table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Third Floor, School of Medicine, Aarabi st., Yaman st., Shahid Chamran hwy.
City
Tehran
Province
Tehran
Postal code
193954719
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.449
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Local infection
Timepoint
1 week after surgery
Method of measurement
Signs such as inflammation and purulent discharge from incision line
2
Description
Wound dehiscence
Timepoint
1 week after surgery
Method of measurement
Wound dehiscence which determined by suegeon
3
Description
Level of pain
Timepoint
1 week after surgery
Method of measurement
Level of pain based on verbal rating scale (VRS) No pain 0 ; Mild pain 1 ; Moderate pain 2; Severe pain 3
4
Description
Scar thickness, mm
Timepoint
1 month after surgery
Method of measurement
Using a ruler on mm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the subcuticular method, the subcutaneous tissue was repaired with absorbable stitches and then, the skin was restored subcutaneously with 3-0 nylon stitches.
Category
Treatment - Surgery
2
Description
Control group: In the transdermal method, the subcutaneous tissue was repaired with absorbent stitches and then the skin was restored simply with 3-0 nylon stitches.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres medical center
Full name of responsible person
Barmak Gholizadeh
Street address
Shahid Modarres medical center, Saadat abad st.
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3109
Email
barmak.gholizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zargi
Street address
3rd Floor, School of Medicine, Arabi st., Yaman st., Shahid Chamran hwy.
City
tehran
Province
Tehran
Postal code
193954719
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Barmak Gholizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres hospital, Saadat Abad st.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3109
Email
barmak.gholizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Barmak Gholizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sahid Modarres hospital, Saadat Abad st.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3109
Email
barmak.gholizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Barmak Gholizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres hospital, Saadat Abad st.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3109
Email
barmak.gholizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It is not yet known if there will be a plan to make this available
When the data will become available and for how long
It is not yet known if there will be a plan to make this available
To whom data/document is available
It is not yet known if there will be a plan to make this available
Under which criteria data/document could be used
It is not yet known if there will be a plan to make this available
From where data/document is obtainable
It is not yet known if there will be a plan to make this available
What processes are involved for a request to access data/document
It is not yet known if there will be a plan to make this available