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General information
Collect 75% of the samples
End of sampling
Collect 75%End of the samplessampling
جمع آوری 75 درصد نمونه ها
پایان نمونه گیری
جمع آوری 75 درصدپایان نمونه هاگیری
Protocol summary
Study aim
Determining the effect of eliminating antibiotic treatment after appendectomy on the prevention of surgical site infection in patients with non-perforated appendicitis
Design
Clinical trial with intervention and control groups, parallel groups, two-way blind, randomized using random number table
Settings and conduct
Patients diagnosed with appendicitis who undergo appendectomy and are diagnosed with non-perforated appendicitis are divided into two groups. 1: They receive a dose of antibiotics before the operation and do not take any more antibiotics after the appendectomy, and instead of antibiotics, they receive a placebo. 2: Receive a preoperative dose of antibiotics and receive the same antibiotics for up to 48 hours. patients and clinicians will not know whether patients are receiving antibiotics or placebo. Patients are examined on an outpatient basis for surgical site infections, one week after surgery, 2 weeks later, and 4 weeks later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with a diagnosis of acute appendicitis referred to Ayatollah Mousavi Medical Center in Zanjan non-admission: immunosuppression, which are: From: 1- Corticosteroids 2- Cancer 3 -Diabetes 4- leukocyte insufficiency 5 -Aids and measles 6 -Nutrition
Intervention groups
Patients are randomly divided into two groups, one group after appendectomy did not receive antibiotics and the outcome will be measured and the outcome will be compared with the group taking antibiotics.
Main outcome variables
Purulent discharge from the wound, redness and inflammation of the wound, the presence of a mass under the skin that has purulent discharge with drainage, abdominal pain, fever
General information
Reason for update
End of sampling
Acronym
IRCT registration information
IRCT registration number:IRCT20210319050743N1
Registration date:2021-03-24, 1400/01/04
Registration timing:prospective
Last update:2021-11-09, 1400/08/18
Update count:6
Registration date
2021-03-24, 1400/01/04
Registrant information
Name
Mohammad Mohammadi arbati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0000
Email address
mohammadarbati@zumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of removing antibiotic therapy after appendectomy in surgical site infection in patients with imperforated appendicitis: A clinical trial
Public title
The effect of eliminating antibiotic treatment after appendectomy on surgical site infectionn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute appendicitis referred to Ayatollah Mousavi Educational and Medical Center in Zanjan
Exclusion criteria:
Immunosuppression in patients undergoing appendectomy
Diabetes
AIDS
Long-term use of corticosteroids
Malnutrition
Cancer
Blood disease with leukocyte insufficiency
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
232
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is block randomization. The size of the blocks is 8 people. Which includes 4 people from the intervention group and 4 people from the control group.
The randomization unit is individual.
Randomization tool is SAS statistical software.
SAS statistical software and PLAN process are used to construct random sequences.
For hiding, a random sequence is created first. Then, based on the sample size of the research, a number of envelopes with aluminum wrappers (In order not to see the contents of the envelopes) are prepared.
Each random sequence is recorded on a card.
The cards are placed in the envelopes of the letters, respectively. In order to maintain a random sequence, envelopes are numbered on the outer surface in the same way. Finally, the envelope lids are glued and placed inside the boxes, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients enter the study after obtaining informed written consent. Patients and the health care provider responsible for injecting the drug do not know if the patient is receiving medication or placebo. Also, the outcome assessor does not know at any stage of the examination that the patient initially received medication or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Gavazang Road, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.ZUMS.REC.1399.115
Health conditions studied
1
Description of health condition studied
Surgical site infection
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure
Primary outcomes
1
Description
Purulent discharge from the wound
Timepoint
Clinical examination in The end of the first, second and fourth weeks After surgery
Method of measurement
History and clinical examination
2
Description
Redness and inflammation of the wound
Timepoint
Clinical examination in The end of the first, second and fourth weeks After surgery
Method of measurement
History and clinical examination
3
Description
stomach ache
Timepoint
Clinical examination in The end of the first, second and fourth weeks After surgery
Method of measurement
History and clinical examination
4
Description
Fever
Timepoint
Clinical examination in The end of the first, second and fourth weeks After surgery
Method of measurement
History and clinical examination
5
Description
Presence of a mass at the surgical site
Timepoint
Clinical examination in The end of the first, second and fourth weeks After surgery
Method of measurement
History and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receive a placebo (distilled water) one cc every 12 hours for 48 hours after surgery
Category
Placebo
2
Description
Control group: They receive one gram of ceftriaxone every 12 hours + 500 mg of metronidazole every 8 hours for up to 48 hours after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Dr. Mohammad Mohammadi Arbati
Street address
Gavazang Road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shaghli
Street address
Dr. Yousef Sabouti Blvd.Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8011
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohammadi Arbati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Gavazang Road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mohammadarbati@zumc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohammadi Arbati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Gavazang Road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mohammadarbati@zumc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohammadi Arbati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Gavazang Road, Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
mohammadarbati@zumc.ac.ir
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
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