Comparison of the Effectiveness of local aftingel ointment and First generation oral cephalosporins in Improving lip mucosal traumatic ulcers(laceration) in patients older than 17 years old
Assessment the effects of Aftingel on healing patients with traumatic wounds of the lip mucosa
Design
A clinical trial with control and intervention groups and with parallel groups, double-blind, simple randomization, phase 2 on 100 patients.
Settings and conduct
The effect of Aftingel on the healing of oral mucosal ulcers in patients who are visited in the emergency room of Alzahra and Kashani centers of Isfahan University of Medical Sciences. The study is double-blind and includes the patients, registerer of results (a constant questioner who is a person other than the researcher).
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient consent to participate in the study, without underlying diseases, not taking any antibiotics, wounds that do not require debridement and size of them less than 5 cm, no malnutrition, simple wounds without any fractures and nerve damage, not using medication that interfere with wound healing. Exclusion criteria: Incomplete information about the type of wound, patient's disinclination to participate in the plan at any time during the study, Wounds that have been created for more than 12 hours.
Intervention groups
Both control and intervention groups receive routine wound treatment, Except that the control group takes antibiotics but intervention group takes Aftingel instead of antibiotics.
Main outcome variables
َAppearance, size and duration of complete wound healing, patient's satisfaction and his pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221004056086N1
Registration date:2022-10-19, 1401/07/27
Registration timing:prospective
Last update:2022-10-19, 1401/07/27
Update count:0
Registration date
2022-10-19, 1401/07/27
Registrant information
Name
Parisa Nasr Isfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 4724
Email address
pnasr0895@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of local aftingel ointment and First generation oral cephalosporins in Improving lip mucosal traumatic ulcers(laceration) in patients older than 17 years old
Public title
Effect of aftingel ointment in healing of mouth ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction to participate in the study
Age older than 17 years
Absence of underlying disease such as liver and kidney disease, Diabetes Mellitus, progressive neurologic disorders, GI disorders and coagulopathy and Wound healing disorders
Not taking any antibiotics for any reason less than 24 hours from the onset of the ulcer
Wounds without requirement to debridement and smaller than 5 cm
without malnutrition
Simple wound without nerve damage and fracture
Not taking medicine with known interference in wound healing
Exclusion criteria:
Incomplete information about type of wound
Patients who don't want to participate in this study at any time during the study
Taking any antibiotics for any reason less than 24 hours from the onset of the ulcer
Wounds that have been created for more than 12 hours
Wounds larger than 5 cm
Age
From 17 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients with ulcers in the mouth area are collected and then randomly assigned to control and intervention groups, and during the sample selection, the patients in each group are matched in terms of sex, cause of ulcer, severity of infection, Age, physical condition and type of nutrition.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, 100 patients with ulcers in the mouth area are collected and then randomly assigned to control and intervention groups (50 people in each group) and a satisfaction form was prepared for each of the experimental units, and complete explanations about how to conduct the study and its interventions are presented to the patients so that the ethical context of the project is respected. Both groups were asked about wound changes (appearance, size and duration of complete healing of wound), pain (based on VAS) and patient's satisfaction (based on Likert scale) and records in the forms prepared for this purpose by a constant questioner, who is not a researcher, and unaware of group's type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No.4, Isfahan university of medical science, Hezar jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-10-11, 1401/07/19
Ethics committee reference number
IR.MUI.MED.REC.1401.259
Health conditions studied
1
Description of health condition studied
Traumatic wounds of the oral mucosa (laceration)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Wound length
Timepoint
On 0, 3 and 7th days of treatment
Method of measurement
graded ruler in centimeters
2
Description
Wound healing time
Timepoint
On 0, 3 and 7th days of treatment
Method of measurement
Based on the length of wound in centimeters until complete wound healing
3
Description
Patient satisfaction
Timepoint
On 0, 3 and 7th days of treatment
Method of measurement
Likert scale
4
Description
pain
Timepoint
On 0, 3 and 7th days of treatment
Method of measurement
Visual analouge scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: preparation of the patient and the doctor, local anesthesia and preferably nerve block of the involved area, cleansing by washing with normal saline and wound repair with the simple suture (if needed) with absorbable thread, mainly vicryl 0-4 or 0-5 with 4 knots at least (depending on wound depth, number of suture layers varies from one to three), rewash with normal saline serum, common oral antibiotic treatment (first generation cephalosporins) for 3 to 7 days Tetanus immunoprophylaxis (according to the standard protocol) is performed routinely in the emergency room and gargling warm salt water solution three times a day at home.
Category
Treatment - Drugs
2
Description
Intervention group: All procedures are similar to the control group, but instead of systemic antibiotic treatment, the patient is treated locally with Aftingel. Open the nozzle and slowly put a drop of Aftin gel on an Qtip and then press it gently for 20 seconds exactly on the wound area and repeat these steps 5 times a day. This is repeated and continued for two weeks, and other wound care items are similar to control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mehradad Nourozi
Street address
Soffe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir
Web page address
https://www.alzahra.mui.ac.ir/
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Saeed Majidinejad
Street address
Kashani Ave.
City
Isfahan
Province
Isfehan
Postal code
81839 83434
Phone
+98 31 3233 0091
Email
dean@med.mui.ac.ir
Web page address
https://www.kashani.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Web page address
https://www.med.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reza Azizkhani
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of Emergency Medicine, Alzahra hospital, Soffe Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 3620 2085
Email
azizkhani1980@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Nasr Isfahani
Position
Resident of emergency medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No. 59, masoud alley, khaiam Ave
City
Isfahan
Province
Isfehan
Postal code
8184653417
Phone
+98 31 3233 4724
Fax
Email
pnasr0895@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Nasr Isfahani
Position
Resident of emergency medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No. 59, masoud alley, khaiam Ave
City
Isfahan
Province
Isfehan
Postal code
8184653417
Phone
+98 31 3233 4724
Email
pnasr0895@gmail.com
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
All data is potentially shareable after de-identifying 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
It will be available for researchers working in academic and scientific institutions and those working in industry.
Under which criteria data/document could be used
Data analysis is allowed for use in other scientific studies. The submitted request will be reviewed by principal and scientific officer of this project, and if both agree, the results will be provided to the applicant.
From where data/document is obtainable
pnasr0895@gmail.com(Parisa Nasr Isfahani)
azizkhani1980@gmail.com(Reza Azizkhani)
What processes are involved for a request to access data/document
After demanders send request's e-mail and explain complete informations about type of required informations and reasons of request and how to use them, will be reviewed their request within a maximum of 3 working days, the documents will be provided to them through the possible channels.