| CTRI Number |
CTRI/2019/08/020883 [Registered on: 26/08/2019] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study and compare the effect of Intralesional Radiofrequency and carbon dioxide Laser in Keloid and hypertrophic Scar |
|
Scientific Title of Study
|
A comparative study of effectiveness of Intralesional Radiofrequency and ultra pulse carbondioxide laser ablation in keloid & hypertrophic scar |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nancy Raiyani |
| Designation |
Junior resident |
| Affiliation |
government medical college and Sir T Hospital Bhavnagar Gujarat |
| Address |
Room No.115
First floor
Department of Dermatology
New OPD building
Sir T General hospital
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9925025024 |
| Fax |
|
| Email |
nancy.raiyani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hita Mehta |
| Designation |
Professor and Head of Department |
| Affiliation |
government medical college and Sir T Hospital Bhavnagar Gujarat |
| Address |
Room No.115
First floor
Department of Dermatology
New OPD building
Sir T General hospital
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
|
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nancy Raiyani |
| Designation |
Junior resident |
| Affiliation |
government medical college and Sir T Hospital Bhavnagar Gujarat |
| Address |
Room No.115
First floor
Department of Dermatology
New OPD building
Sir T General hospital
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
|
| Fax |
|
| Email |
nancy.raiyani@gmail.com |
|
|
Source of Monetary or Material Support
|
| 115
First floor
Department of dermatology
Sir T General Hospital and Government Medical College Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of dermatology Government Medical College Bhavnagar |
| Address |
115
First floor
Department of Dermatology
New OPD building
Sir T General Hospital and Government Medical College
Jail road
Bhavnagar
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nancy Raiyani |
Sir T. Hospital and Government medical college, Bhavnagar |
Room No.115, dermatology OPD,
Sir T Hospital Bhavnagar Gujarat
Bhavnagar
GUJARAT |
9925025024
nancy.raiyani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Government Medical College Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L910||Hypertrophic scar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carbon dioxide Laser Surface ablation |
Technique- single or stagewise manner by multiple puncture technique
Small full thickness punctures will be created throughout the keloid tissue with a gap of 1-3 mm between the two punctures by CO2 laser. Single pulse (for firm keloid) or continuous (for hard keloid) mode will be used with 20 W power
Injection triamcinolone acetonide 20 mg/ml will be infiltrated around the margins just after surgery and again after a gap of every 4 weeks for 6 months
The same procedure will be repeated every monthly consequently for 3 months, if needed(until excellent response achieved) |
| Intervention |
Intralesional Radiofrequency ablation |
The device used-RF generator.
Mode - cut/ coagulation
Max. power output of 10 W.
Intracath no 22 will be used with the insulation and small nick was made at the base of middle and the tip of a needle
The uninsulated part of the intracath tip will be inserted into the keloid, and the pre-set energy will be applied to the keloid tissue until a maxi temperature of 90°C will be reached
Injection triamcinolone acetonide 20 mg/ml will be infiltrated around the margins just after surgery and again after a gap of every 4 weeks for 6 months
The same procedure will be repeated every monthly consequently for 3 months, if needed(until excellent response achieved) |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Keloid and hypertrophic scar
Progressive or Stationary lesion
Size <10 cm in any dimension
No previous treatment in last 6 weeks
|
|
| ExclusionCriteria |
| Details |
Pedunculated lesion
Sensitivity to local anesthetic
Pregnant females
Infected or secondary changes on surface (e.g. excoriation/ eczema)
Person with Pacemaker
Person with unstable general condition
Patient not willing for consent and follow up
Patient in need of alternative treatment during the treatment course |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Excellent response (90 %- almost complete flattening)
Good response (71-90 % Significant flattening)
Moderate response (51-70 % Adequate flattening)
Poor response (≤50 % Inadequate flattening)
|
28 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Size
Height
The Vancouver Scar Scale |
0 week
16 weeks
28 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Keloid and hypertrophic scars are caused by disturbance in normal healing process. Delay in wound healing, infection, foreign material in wound, tension on area, hormonal status, genetic constitution, etc. are few of the factors that affect the formation of keloid and its recurrence.
Available different treatment options:
intralesional steroid,
surgical excision,
cryotherapy,
pressure therapy,
silicone gel sheet application,
radiotherapy,
laser therapy,
botulinum toxin, etc.
But, none of the therapeutic option for the treatment of keloid has been found completely effective and satisfactory. Mostly, combination of treatments is necessary for better outcome.
Surgical excision with modification often tried for good cosmesis and/or symptom relief, but mostly complicated by recurrence of keloid. radiofrequency heating is used to create targeted coagulation and necrosis that result in reduction of volume in treated area. In co2 laser, 10,600nm laser light is used for selective photothermolysis of full thickness tissue. Intralesional injection following the procedure is given for suppression of tissue regrowth. The procedure will be done under local anesthesia. Study Methodology:
Keloid or hypertrophic scar will be photographed, measured and assessed with other different scales (VSS, POSAS) and noted on Case Record Form with Consent of the Participant or Guardian (in case of minor) after full explanation of the procedure, side effect, other modalities, outcome and other queries.
The chosen procedure will be repeated every monthly (in needed) followed by intralesional injection for consequently 3 months after reassessment of the lesion. Intralesional injection will be carried out monthly for total duration of 6 months(counting from 1st procedure done) Side effects:
Pain/ itching at treatment site
Edema/ ulcer/ bullae at treatment site
Post procedure advice:
Do not touch/ press repeatedly and scratch over treatment area
On notice of above side effect, inform your treatment doctor as soon as possible
Avoid direct exposure of wound to sunlight and dust
Complete the given medicines
Be on regular follow up for further treatment
Outcome:
Treatment site may not look completely as normal surrounding skin
One or more treatment at same site may be needed at same site.
Recurrence of keloid may happen at treatment site which depends upon physical nature of the person |