Comparison the complications of two wound repair methods (subcuticular and mattress) in patients undergoing appendectomy
Design
Randomized clinical trial with parallel groups which will be conducted on 200 patients undergoing appendectomy
Settings and conduct
This study will be conducted with the aim of comparison the complications of two wound repair methods (subcuticular and mattress) in 200 patients undergoing appendectomy. After inclusion in the study, using block randomization method with blocks of 20, the patients will be assigned into two groups; intervention group 1 undergoing subcuticular suture for the skin incision and intervention group 2 undergoing matress suture for the skin incision. Pain severity will be measured by Visual Analog Scale (VAS) and surgical site infection will be evaluated by direct observation the signs of infection and will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criterion: age of 18-50 years old.
Exclusion criteria: perforated appendicitis; immunodeficiency; body Mass Index of more than 30 kg/m2.
Intervention groups
Intervention group 1: undergoing subcuticular suture for the skin incision.
Intervention group 2: undergoing matress suture for the skin incision
Main outcome variables
Surgical site infection; post-operation pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180820040840N1
Registration date:2018-09-10, 1397/06/19
Registration timing:prospective
Last update:2018-09-10, 1397/06/19
Update count:0
Registration date
2018-09-10, 1397/06/19
Registrant information
Name
Hamidreza Haghighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
dr.haghighi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the complications of two wound repair methods (subcuticular and mattress) in patients undergoing appendectomy
Public title
Comparison the complications of two wound repair methods (subcuticular and mattress) in patients undergoing appendectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 50 years old
Being candidate for appendectomy
Exclusion criteria:
Perforated appendicitis
Immunodeficiency
Body Mass Index of more than 30 kg/m2
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 20
Considering the sample size of 200, 10 blocks with 20 cards (10cards for each group) will be selected; by selecting each block, 10 patients will be assigned into each group.
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 Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR. ZAUMS. REC.1397.106
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Surgical site infection
Timepoint
During the patient's hospitalization period
Method of measurement
By direct observation of the signs of infection
2
Description
Post-operation pain severity
Timepoint
0, 6, 12, 24 hours after the surgery
Method of measurement
By using the Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: undergoing subcuticular suture for the skin incision
Category
Treatment - Surgery
2
Description
Intervention group 2: undergoing matress suture for the skin incision
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Hamidreza Haghighi
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Haghighi
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Haghighi
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Haghighi
Position
Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
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