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
-
Completion of the trial
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210319050743N1
Registration date:
2021-03-24, 1400/01/04
Registration timing:
prospective
Last update:
2022-01-02, 1400/10/12
Update count:
6
-
Registration date
-
2021-03-24, 1400/01/04
-
Registrant information
-
-
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
-
2021-05-18, 1400/02/28
-
Actual recruitment end date
-
2021-10-30, 1400/08/08
-
Trial completion date
-
2021-11-29, 1400/09/08
-
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
Actual sample size reached:
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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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