1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of oral Gabapentin with injectable chlorpheniramine in the form of mesotherapy on the control of itching caused by hypertrophic scars in burn patients

Protocol summary

Study aim
Comparison of effectiveness of mesotherapy with chlorpheniramine and oral drug therapy with gabapentin on controlling itching caused by hypertrophic scar in burn patients
Design
A controlled, parallel-group, double-blind, randomized clinical trial study on 40 patients. Block randomization method is used for randomization.
Settings and conduct
The samples were selected from patients suffering from itching caused by hypertrophic scar referred to Amirul Mominin burn hospital in Shiraz and divided into two groups. Blocked and double-blind randomized method is used, and the study begins after obtaining written consent. In the control group, we perform oral gabapentin treatment and in the intervention group, chlorpheniramine mesotherapy, and finally we measure their effect in reducing the itch of the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 65 years - history of burns less than 10% TBSA - second or third degree burns - itching caused by hypertrophic scars after burns - at least two months have passed since the burn Exclusion criteria: receiving a graft, uncontrolled diabetes, infection due to a burn wound, suffering from chemical or electrical burns, burns in the perineum or face, history of allergy or allergic reaction to medicine, history of peripheral neuropathy and itchy skin disease such as psoriasis, history of Epilepsy and use of anticonvulsant drugs, history of uncontrolled kidney, heart, liver, cancer, or pregnancy and breastfeeding, use of anticoagulants
Intervention groups
The intervension group receiving chlorpheniramine mesotherapy along with massage and compression garnmant And The control group receiving oral gabapentin along with massage and compression garnment
Main outcome variables
The degree of pruritus, patients' quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230731058993N1
Registration date: 2024-08-10, 1403/05/20
Registration timing: prospective

Last update: 2024-08-10, 1403/05/20
Update count: 0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Zahra Setoodeh nia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 2925
Email address
z.setoodeh74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-11, 1403/05/21
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral Gabapentin with injectable chlorpheniramine in the form of mesotherapy on the control of itching caused by hypertrophic scars in burn patients
Public title
Investigating the effect of Gabapentin and chlorpheniramine mesotherapy on itching caused by hypertrophic burn scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being 18-65 years old Completing and signing the inform consent form Clinical diagnosis of hypertrophic burn scar At least two months have passed since the burn Burn less than 10% of TBSA Having pruritus Having history of second or third degree burns
Exclusion criteria:
Receiving a skin graft after a burn, patients suffering from wound infection due to burns, patients suffering from burns caused by chemicals or electric shock, suffering from perineal or facial burns, suffering from uncontrolled diabetes, inability to communicate and complete the questionnaire. having peripheral neuropathy or psoriatic skin diseases, history of epilepsy and taking anticonvulsant drugs, history of allergies and allergic reactions to used drugs, history of significant liver, kidney, brain, and cardiopulmonary disorders , pregnant women and lactating women, people who have cancer, people who are using anticoagulants
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In order to match the intervention and control group patients, the patients are randomly assigned. Block Randomization Assignment and double-blind method will be used for randomization in this study. We will have two lists of 20 people including two intervention and control groups randomly. In order to hide the random sequence method, another person who is unaware of the research process is provided, and the questionnaires are completed by a person who is unaware of the division of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: In this study, we do not have the ability to blind the patients, because the patients of both interventions know the type of intervention. Clinical Caregiver: We teach the person who is in charge of the care and follow-up of the patients how to complete the questionnaire. This person has no knowledge of the type of patient intervention. Researcher: In this study, we do not have the ability to blind the researcher, because the researcher conducts both studies himself and knows the type of intervention received in each group. Outcome evaluator: Completed questionnaires are given to a person who does not know about the interventions and he is asked to determine the amount of pain reduction and performance increase in each person according to the questionnaire. Data analyst: Finally, after completing and collecting all the information, the questionnaires are given to a person to check the information, who does not know about any of the work steps and how the intervention is divided.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Seventh floor, The central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.SUMS.MED.REC.1402.500

Health conditions studied

1

Description of health condition studied
Itching caused by hypertrophic scars after burns
ICD-10 code
L29
ICD-10 code description
Pruritus

Primary outcomes

1

Description
Pruritus
Timepoint
before the intervention and one, three, seven, fourteen, twenty-eight days later and two months after the intervention
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Quality of life of patients
Timepoint
Before the intervention, fourteen and twenty-eight days later and two months after the intervention
Method of measurement
DLQI quality of life questionnaire

Intervention groups

1

Description
Intervention group: subcutaneous injection of 1 ml of chlorpheniramine (mesotherapy) 10 mg along with 1 ml of lidocaine 2% in the healthy skin around the hypertrophic scar. Mesotherapy is carried out in three stages with an interval of one week according to the common sterile protocol along with the recommendation to perform daily 3-stage massage for 4 times a day and use compression garnment for at least 2 months. Before entering the study and 1, 3, 7, 14, 28 days later and 2 months later, the patients determine the intensity of itching with the VAS scale. And before entering the study and also 14, 28 days after and two months after entering the study, they complete the form related to the evaluation of the quality of life(DLQI)
Category
Rehabilitation

2

Description
Control group: Oral gabapentin is prescribed with an appropriate dose based on the severity of itching. Also, the patients are taught how to perform 3-step massage 4 times a day, and the patients are emphasized to use compression garnmet along with the two mentioned treatments for two months. Before entering the study and 1, 3, 7, 14, 28 days later and 2 months later, the patients determine the intensity of itching with the VAS scale. And before entering the study, as well as 14, 28 days later and two months after entering the study, they complete the form related to the evaluation of the quality of life (DLQI).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirul Mominin Burn Accident Hospital
Full name of responsible person
Mohammad Mehdi Aslani
Street address
Sadra City
City
Shiraz
Province
Fars
Postal code
7198753854
Phone
+98 71 3614 6101
Fax
+98 71 3622 0437
Email
Amiralmomeninbh@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammd Hashem Hashem poor
Street address
The central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
Info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Setoodeh nia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 6, No. 236, Alley 8, Mahalati St, West Qudousi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7186835367
Phone
+98 71 3631 2925
Email
z.setoodeh74@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Setoodeh nia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 6, No. 236, Alley 8, Mahalati St, West Qudousi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7186835367
Phone
+98 71 3631 2925
Email
Z.setoodeh74@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Setoodeh nia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Unit 6, No. 236, Alley 8, Mahalati St, West Qudousi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7186835367
Phone
+98 71 3631 2925
Email
Z.setoodeh74@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 available data can be shared after de-identifying individuals.
When the data will become available and for how long
Access starts one year after results are published
To whom data/document is available
Everyone will have access to this information
Under which criteria data/document could be used
If the information of this study helps in improving the process of science.
From where data/document is obtainable
Dr.Zahra Setoodeh nia , 09173507027, Z.setoodeh74@gmail.com
What processes are involved for a request to access data/document
After sending the desired message, all the authors of this study will be discussed, and if necessary, all information will be sent within a maximum of three weeks.
Comments
Loading...