Determining the combined effect of intralesional injection of triamcinolone and verapamil in the treatment of keloid scar after surgery
Design
Clinical trial with control and intervention group, with parallel, randomized groups
Settings and conduct
The group receiving triamcinolone without verapamil. The group receiving verapamil with triamcinolone (group 2) are randomly divided by Randomized Block method. Patients will go to Imam Reza Surgery Clinic of Poursina and Velayat Hospital and visiting by the surgeon will be investigated
Participants/Inclusion and exclusion criteria
In this study, the necessary information will be recorded in a questionnaire by the interviewer. Demographic information of patients (age, sex) as well as information about scars (size ,length, width, height), Percentage of flattening, redness of the lesion, pigmentation, flexibility,severity of itching and type of injection are recorded in their file. Other scars are also treated with triamcinolone according to routine protocols.
Intervention groups
Triamcinolone group (first group).
Triamcinolone and verapamil group (group2)
Evaluation of the combined effect of intralesional injection of Triamcinolone and Verapamil in the treatment of post-surgery Keloid scars
Public title
Triamcinolone and Verapamil injection on Keloid scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Keloid scar should be at least 0.5 cm long and at most 10 cm
At least 3 months will be passed since their surgery
Patients are in the age range of 18 to 50 years
consent Informed
Exclusion criteria:
Keloid scars with a duration of more than 12 months
Patients with infection or any other disease in the vicinity of the wound
Pregnant patients or those who plan to become pregnant in the near future
Breastfeeding women
Diabetic patients
Patients with high blood pressure or heart problems
People with chronic kidney disease or those who have had any abnormal changes in the CBC or liver tests
Patients taking steroids or verapamil for other conditions
Keloid scars of the head, face and neck
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, limited randomization will be used as a block randomization method to design patients into intervention and control groups. The latest allocation will prevent the direction from being detected in the blocks under consideration; the size of the blocks is considered random, with 2 or 4
It will use R software to generate random numbers using the Runif command.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
in front of 17 Shahrivar Hospital - St. - Shahid Siadati St. -
City
Rasht
Province
Guilan
Postal code
4193713111
Approval date
2021-08-11, 1400/05/20
Ethics committee reference number
IR.GUMS.REC.1400.227
Health conditions studied
1
Description of health condition studied
Surgical keloid lesion
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
length, Width, height of Keloid
Timepoint
Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions
Method of measurement
Observer measurement by calibrated compass
2
Description
Redness of the lesion
Timepoint
Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions
Method of measurement
Based on the description of the Oscar method
3
Description
Pigmentation
Timepoint
Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions
Method of measurement
Based on the description of the Oscar method
4
Description
Flexibility
Timepoint
Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions
Method of measurement
Based on the description of the Oscar method
5
Description
Severe itching
Timepoint
Upon arrival and after each injection session until the lesion is completely flattened or up to 8 sessions
Method of measurement
Based on the description of the Oscar method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients which are candidate of receiving triamcinolone (without verapamil), Injections into scars with Insulin gauge syringe No. 24 without local anesthesia and intralesional injection of triamcinolone acetonide (Caspian khazar Triam Company) at a concentration of 40 mg / ml and a maximum dose of 2 mg per scar per session are performed.
Category
Treatment - Drugs
2
Description
Group receiving triamcinolone and verapamil (group 2) Scar injections with insulin gauge syringe number 24 without local anesthesia and intralesional injection of verapamil (myland verapamil) 2.5 mg / ml with a maximum dose of 2.5 mg and triamcinolone At a concentration of 40 mg / ml and a maximum dose of 2 mg per scar per session.