Therapeutic
Comparison of wound healing rate in two groups of topical moxifloxacin and placebo
Design
Control-controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 80 patients used the Excel software rand function for randomization
Settings and conduct
This project will take place at Shahid Sadoughi Hospital in Yazd. Patients in two groups of 40 people use moxifloxacin cream twice a day for 5 days
In order to evaluate the effectiveness of moxifloxacin cream in wound healing at the surgical site, we give a group of 40 people with moxifloxacin and a group of 40 people with a placebo.
Main outcome variables
Age
Sex
Redness
Edema
Ecchymosis
Discharge
Approximation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N5
Registration date:2021-10-25, 1400/08/03
Registration timing:prospective
Last update:2021-10-25, 1400/08/03
Update count:0
Registration date
2021-10-25, 1400/08/03
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical moxifloxacin effevtiveness and placebo in general Surgeries wound healing
Public title
Evaluation of moxifloxacin effevtiveness in wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have undergone general surgery
Patients over 18 years old
In this study, 80 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 10 blocks of 8 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 80 is in 10 blocks of eight in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 80.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients, clinical caregivers and outcome assessors were unaware of the type of medication patients were receiving. Patients in both groups received the medication in the same package.
After randomization of the questionnaires, the statistics consultant was provided, and she divided the patients into two groups of 40 based on the numbers written in the questionnaire and using a table of random numbers.
To blinding the drug tubes with the same appearance, which deprives the researcher and patients of identifying the drug from Placebo, it was prepared by a clinical pharmacologist and provided to the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science,Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.080
Health conditions studied
1
Description of health condition studied
Wounds from the site of general surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Review of the Redness, Edema, Ecchymosis, Discharge, Approximation index
Timepoint
Days 0, 1, 3 and 5 after surgery
Method of measurement
Observational
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients use moxifloxacin cream on the suture site for 5 days after surgery. In this study, 80 patients were randomized into two treatment groups (A and B). In both groups, the topical product was used on the wound three times per day. All patients were taught non-pharmacological procedures such as washing, proper wound dressing, and how to care for the wound. The two groups were not different in terms of non-pharmacological measures.
Category
Treatment - Drugs
2
Description
Control group: Patients use placebo cream on the suture site for 5 days after surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid sadoughi hospital
Full name of responsible person
Saeed kargar
Street address
Ibn Sina Street, Shahid Ghandi Boulevard, Safaieh
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Email
sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid sadoughi university of medical science,shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid sadoughi university of medical sciences,shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid sadoughi university of medical sciences,shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences,Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.