| CTRI Number |
CTRI/2024/11/077425 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [healing] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of healing of facial wound with and without application of amniotic membrane |
|
Scientific Title of Study
|
Efficacy of Amniotic Membrane on healing of facial abrasion wounds - A Clinical Comparative Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Raut |
| Designation |
PG student |
| Affiliation |
Dr.D.Y.Patil Dental College and Hospital, Pimpri, Pune |
| Address |
Room number 9,Department of Oral and Maxillofacial Surgery,Dr.D.Y.Patil Dental College and Hospital,Dr.D.Y.Patil Vidyapeeth Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8805251958 |
| Fax |
|
| Email |
shubhamraut117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubham Raut |
| Designation |
PG students |
| Affiliation |
Dr.D.Y.Patil Dental College and Hospital, Pimpri, Pune |
| Address |
Room number 9,Department of Oral and Maxillofacial Surgery,Dr.D.Y.Patil Dental College and Hospital,Dr.D.Y.Patil Vidyapeeth Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
8805251958 |
| Fax |
|
| Email |
shubhamraut117@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Raut |
| Designation |
PG student |
| Affiliation |
Dr.D.Y.Patil Dental College and Hospital, Pimpri, Pune |
| Address |
Room number 9,Department of Oral and Maxillofacial Surgery,Dr.D.Y.Patil Dental College and Hospital,Dr.D.Y.Patil Vidyapeeth Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
8805251958 |
| Fax |
|
| Email |
shubhamraut117@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 9,Department of Oral and Maxillofacial Surgery,Dr.D.Y.Patil Dental College and Hospital,Dr.D.Y.Patil Vidyapeeth Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Shubham Raut |
| Address |
Room number 9,Department of Oral and Maxillofacial Surgery,Dr.D.Y.Patil Dental College and Hospital,Dr.D.Y.Patil Vidyapeeth Pimpri, Pune |
| 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 |
| DrShubham Raut |
Department of Oral and Maxillofacial Surgery |
Room number 9,Department of Oral and Maxillofacial Surgery,Dr.D.Y.Patil Dental College and Hospital,Dr.D.Y.Patil Vidyapeeth Pimpri, Pune
Pune
MAHARASHTRA |
8805251958
shubhamraut117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee, Dr.D.Y.Patil Dental College and Hospital, Dr.D.Y.Patil Vidyapeeth, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V899||Person injured in unspecified vehicle accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic Membrane |
Lyophilised dry amniotic membrane applied and sutured with 3-0 silk sutures |
| Comparator Agent |
No application of membrane |
Cleaning of wound with normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with fresh abrasion wounds.
Patients who are willing to undergo treatment.
Above 18yrs of age.
|
|
| ExclusionCriteria |
| Details |
Patients with infected facial abrasion wounds. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of the facial abrasion based on Healingindex by Landry and Turnbull |
3 months, 6 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| aesthetics , How well has the abrasioon blended with the surrounding tissue |
3 months, 6 months, 1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
To investigate whether Amniotic scaffold can modulate the healing of a wound by promoting tissue reconstruction rather than promoting scar tissue formation. Amniotic membrane is an attractive method of grafting for wounds as it has unique properties, including anti-inflammatory effects, bacteriostatic, wound protection, decreased scarring, and pain reduction properties, as well as epithelialization initialization capacities. Furthermore, Amniotic Membrane is widely available and less costly than other bioengineered skin substitutes. Abrasions are generally minor injuries and tend to heal within two weeks without any resultant scarring. Extensive and deep abrasions, as well as infection, may result in scarring, which can be prevented by daily cleaning and dressing. Debridement should be performed to avoid extensive cicatrization. |