| CTRI Number |
CTRI/2023/11/060389 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study effect of Scarxgen Silicone Gel Sheet in management of scars developing after surgery |
|
Scientific Title of Study
|
A Prospective, Non-Comparative, Open-label, Single-arm Clinical Study to Evaluate the efficacy of SCARXGEN in the management of post-surgical scars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Athira Gopinathan |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital & Research Centre |
| Address |
Department of General Surgery
SRM Medical College Hospital and Research Centre
Kattankulathur
Tamilnadu 603203
Chennai
TAMIL NADU
603203
India |
| Phone |
9677161953 |
| Fax |
|
| Email |
athirag@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Hari Kishore |
| Designation |
Director |
| Affiliation |
REGENXGEN BIOSOLUTIONS PRIVATE LIMITED |
| Address |
9A II Floor
Lourdhu Madha Street
Nagalkeni
Chrompet
Chennai 600044
Chennai
TAMIL NADU
600044
India |
| Phone |
9884974340 |
| Fax |
|
| Email |
dr.vanita@regenxgen.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Hari Kishore Sridharan |
| Designation |
Director |
| Affiliation |
REGENXGEN BIOSOLUTIONS PRIVATE LIMITED |
| Address |
9A II Floor
Lourdhu Madha Street
Nagalkeni
Chrompet
Chennai 600044
Chennai
TAMIL NADU
600044
India |
| Phone |
9962174340 |
| Fax |
|
| Email |
hari.kishore@regenxgen.com |
|
|
Source of Monetary or Material Support
|
| Regenxgen Biosolutions Private Limited, 9A, II Floor, Lourdhu Madha Street, Nagalkeni, Chrompet, Chennai 600044, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Regenxgen Biosolutions Private Limited |
| Address |
9A, II Floor, Lourdhu Madha Street, Nagalkeni, Chrompet, Chennai 600044, Tamilnadu, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Athira Gopinathan |
SRM Medical College Hospital |
3rd Floor,
SRM Medical College Hospital & Research Centre,
SRM Nagar
Potheri
Kattankulathur 603023
Tamilnadu
India
Chennai
TAMIL NADU |
9677161953
athirag@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
Not Applicable as it is Single Arm Study |
Not Applicable as it is Single Arm Study |
| Intervention |
Silicone Gel Sheet (Brand Name : Scarxgen) |
Silicone Gel Sheet is soft, clear, transparent, conformable, re-usable self-adhesive sheet made of medical grade silicone, adhered on release liner. Silicone Gel Sheet is supplied non-sterile in medical grade peel open pouches. The product can be cut to size depending on the size of the scar. Silicone Gel Sheet is biocompatible as per applicable ISO 10993 standards. Among the brands available, SCARXGEN will be used for this study representing all other brand names and will be supplied in dimensions for clinical study according to the corresponding study protocol. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Both Male and female patients aged above 3 years
2. Patients with post-surgical linear hypertrophic scars and/or keloids with Age of Hypertrophic Scars and/keloids between 2 months to 2 years and Size of Scar: Less than 30cm in length (Length < 30cm)
3. Patients who can understand and follow specific instructions of the hospital as far as application, removal, storage, and re-application of the study product in a systematic manner
4. Patients or patients with parents/guardians who can and are willing to provide written informed consent
5. Patient who understands and is willing to participate in the clinical study and can comply with scheduled visits as per the protocol and follow-up study procedures |
|
| ExclusionCriteria |
| Details |
1.Patient with signs of wound dehiscence, wound infection, open wounds in the post-operative area at the time of first application
2. Patient who has received any type of hypertrophic scar or keloid treatment within 4 weeks prior to start of the current study or planning to undergo another parallel treatment for hypertrophic scars or keloids
3. Patients having history of developing genetic keloids
4. Patients with history of collagen vascular disease, connective tissue disease (cutis laxica), systemic psoriasis, lupus or scleroderma
5. Patient with known allergy/ hypersensitivity to medical tapes, or adhesives, silicone gel sheet or any of the individual polysiloxane based products
6. Patients with pitted or depressed scars as per clinical assessment
7. Patients having dermatological conditions (For example: Psoriasis, Eczema etc.)
8. Presence of any condition(s) that seriously compromises the patient’s ability to complete this study or has a known history of poor adherence with medical treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in scar appearance
2. Effective reduction in total scar size |
Screening Period plus 24 weeks of treatment period assessed at Baseline Visit and follow up visits on Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Event Monitoring |
24 weeks of Study Period |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/12/2023 |
| Date of Study Completion (India) |
31/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Silicone Gel Sheet (Brand Name: Scarxgen) is soft, clear, transparent, conformable, re-usable self-adhesive sheet made of medical grade silicone, adhered on release liner. Silicone Gel Sheet is supplied non-sterile in medical grade peel open pouches. The product can be cut to size depending on the size of the scar. Silicone Gel Sheet is biocompatible as per applicable ISO 10993 standards. Scarxgen is indicated for use in prevention and/or management of old and newly formed, red and raised scars (Hypertrophic Scars/Keloids). Scarxgen’s ability to provide semi-occlusion and modulate water vapour transmission to enable hydration to the scar is its key novel feature. Scarxgen offers gentle adhesion to healthy skin, thereby enabling painless and atraumatic removal. Scarxgen is a CE certified Medical Device as per European Medical Device Regulations - EU MDR 2017/745. This Clinical Study is aimed at measuring the efficacy of Scarxgen on post-surgical scars with focused on scars developing Post-Orthopedic, Post- Gynecological, Post- General Surgery and Post- Cardio-thoracic surgeries |
|