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Investigating the effect of preoperative vitamin D consumption on surgical site infection

Protocol summary

Study aim
Determining the effect of preoperative vitamin D consumption on surgical site infection in gynecological surgeries
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 220 patients, using the randomized block method using sealed envelope software.
Settings and conduct
Double-blind clinical trial, study population: patients who refer to educational and treatment centers in Kashan and Beheshti who are candidates for elective gynecological surgeries such as (hysterectomy, ovarian cyst, oophorectomy and cancers).
Participants/Inclusion and exclusion criteria
Candidate patients for elective gynecological surgeries (hysterectomy, caesarean section, oophorectomy and ovarian cyst, cancer) Women over 18 years old and under 80 years old Willingness of patients to participate in research Not receiving corticosteroids or immunosuppressive drugs Unwillingness to continue participating in the study Patients with serum vitamin D levels below 30 and above 70 ng Patients who need re-surgery for medical reasons (bleeding, unsuccessful first surgery, etc.) laparoscopic surgeries or emergency surgeries (only open elective surgeries are considered)
Intervention groups
In the intervention group, in addition to routine care before and after surgery, they received 2 tablets of 50,000 units of vitamin D (one tablet every week), and in the control group, patients received a placebo in addition to routine care before and after surgery for the purpose of blinding the study. will have no therapeutic effect on the patient. In all patients undergoing surgery, the serum level of vitamin D will be recorded and analyzed before and after surgery.
Main outcome variables
Reducing surgical site infections in gynecological surgeries

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240419061523N1
Registration date: 2024-05-09, 1403/02/20
Registration timing: prospective

Last update: 2024-05-09, 1403/02/20
Update count: 0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Nahid Norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5510 3142
Email address
norouzi-na@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of preoperative vitamin D consumption on surgical site infection
Public title
Investigating the effect of vitamin D on surgical site infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for elective gynecological surgeries (hysterectomy, oophorectomy and ovarian cyst, cancer) Women over 18 years old and under 80 years old Willingness of patients to participate in research Not receiving corticosteroids or immunosuppressive drugs
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups by block randomization method. For random allocation, the random block method will be used, the list of which is prepared by sealed envelope computer software, and it includes 22 blocks of 10 in each block, 5 samples from each test and control group, and 110 samples from each group will participate in the total blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In addition to routine care before and after surgery, the intervention group will receive 2 tablets of 50,000 units of vitamin D two weeks before surgery(one tablet every week) and in the control group, patients will receive a placebo in addition to routine care before and after surgery for the purpose of blinding the study. which has no therapeutic effect on the patient. The placebo used will be exactly the same size, shape and taste as the vitamin D pill and will be ordered from a pharmaceutical company that uses this vitamin (Dana Pharmaceuticals).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2024-03-01, 1402/12/11
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.272

Health conditions studied

1

Description of health condition studied
Surgical site infections in gynecological surgeries
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure

Primary outcomes

1

Description
The incidence of surgical site infection in gynecological surgeries
Timepoint
Examining the rate of infection on days 1, 3, 7 and 30 after surgery
Method of measurement
Based on the symptoms of infection (swelling, redness, erythema, pain, purulent secretions and fever), which is confirmed by the relevant surgeon.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to routine care before and after surgery, the intervention group will receive 2 tablets of 50,000 units of vitamin D (Dana Pharmaceutical Company) (one tablet every week) 2 weeks before surgery.
Category
Treatment - Drugs

2

Description
Control group: In the control group, in addition to routine care before and after surgery to blind the study, patients will receive a placebo that has no therapeutic effect on the patient. The placebo used will be exactly the same as vitamin D tablets in terms of size, shape and taste The pharmaceutical company that uses this vitamin (Dana Pharmaceutical Company) will be ordered.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Nahid Norouzi
Street address
Beheshti Hospital, Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 3142
Email
norouzi-na@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Gholamali Hamidi
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Nahid Norouzi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Operating room technology
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 3142
Email
norouzi-na@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nahid Norouzi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Operating room technology
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 3142
Email
norouzi-na@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nahid Norouzi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Operating room Technology
Street address
Pezeshk Blvd, Qotb–e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 3142
Email
norouzi-na@kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome can be shared after de-identification of individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The researchers' request will be reviewed and sent by sending the official academic email.
From where data/document is obtainable
Nahid Norouzi norouzi-na@kaums.ac.ir
What processes are involved for a request to access data/document
The researchers' request will be reviewed and sent by sending the official academic email.
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