| CTRI Number |
CTRI/2023/03/051208 [Registered on: 31/03/2023] Trial Registered Prospectively |
| Last Modified On: |
29/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
evaluation of how scars heal after a surgery using silicone gel versus silicone gel sheet |
|
Scientific Title of Study
|
Comparative evaluation of post operative scarring with nasolabial flap reconstruction using silicone gel versus. silicone gel sheet : randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRia Raghavan |
| Designation |
PG resident Department of Oral and Maxillofacial Surgery |
| Affiliation |
DrDY Patil Dental College and Hospital |
| Address |
DrDY Patil Dental College and Hospital, Sant Tukaram Nagar , Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9711041276 |
| Fax |
|
| Email |
21040042.dental@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSonal B Shah |
| Designation |
MDS Professor |
| Affiliation |
DrDY Patil Dental College Hospital |
| Address |
DrDY Patil Dental College and Hospital, Sant Tukaram Nagar , Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9833459822 |
| Fax |
|
| Email |
sonal.shah@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSonal B Shah |
| Designation |
MDS Professor |
| Affiliation |
DrDY Patil Dental College Hospital |
| Address |
DrDY Patil Dental College and Hospital, Sant Tukaram Nagar , Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9833459822 |
| Fax |
|
| Email |
sonal.shah@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Ria Raghavan |
| Address |
I 1202A Ajnara Integrity Rajnagar extension ghaziabad 201017 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Ria Raghavan |
Department of Oral and Maxillofacial Surgery |
Department number 9, 3rd floor
DrDY Patil Dental College and Hospital, Sant Tukaram Nagar , Pimpri, Pune
Pune
MAHARASHTRA |
9711041276
21040042.dental@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Dy Patil Vidyapeeth Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Silicone gel |
To be used twice daily for three months. Evaluation will be done every 2 weekly for initial 3 months and then at the end of 6 months |
| Comparator Agent |
Silicone gel sheet |
Sheet application will be prescribed
Gel application will be prescribed twice daily for 3 months.
for 4 hours on day 1, increasing it. by 2 hours a day till 1 week and then 24 hourly until 3 months. Evaluation of wound healing will be done every 2 weeks for first 3 months and then after end of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Operated cases of reconstruction with bilateral nasolabial flap.
2. Patients in the age group 18-50 years. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of hypersensitivity reactions.
2. Patients with systemic disorders like diabetes, hypertension, blood dyscrasias.
3. Patients with history of keloid formation.
4. Patients with scar more than 3 months old.
5. Patients with open or infected wounds, scabs of stitches.
6. Patients having skin affected by acne. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post op scarring |
every 2 weeks for first 3 months and then after end of 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| scar healing |
Evaluation of wound healing will be done every 2 weeks for first 3 months and then after end of 6 months. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
01/04/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cosmetic disfigurement following surgical procedures on the face has been an area of concern. Even after achieving closure in layers and following microsurgical suturing techniques, there are tendencies of formation of hypertrophic scars and keloids. Treatment of scars is a life changing procedure for a patient . Nasolabial flaps are routinely used for reconstruction following various surgical procedures. Even though the incision is taken in a skin crease, but it still has a tendency to leave a scar. We hereby intend to check the effect of silicone gel and silicone gel sheet on post-operative scarring with nasolabial flap reconstruction |