| CTRI Number |
CTRI/2024/11/076334 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Treating 26 patients with finger tip injuries with a dressing material which is an artificial collagen material in healing of wound for good functional and aesthetic outcome |
|
Scientific Title of Study
|
Role of bilayer dermal substitute with secondary grafting in fingertip injuries |
| 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 Neeti Jamwal |
| Designation |
Senior Resident, Dept of Plastic Surgery |
| Affiliation |
VMMC and Safdarjung Hospital , Ansari nagar, New Delhi , 110029 |
| Address |
Department of burns and plastic surgery, First floor, Near Ward 22A, VMMC and Safdarjung Hospital, Ansari nagar , New Delhi
Department of burns and plastic surgery, First floor, Near Ward 22A
New Delhi
DELHI
110029
India |
| Phone |
8825067429 |
| Fax |
|
| Email |
neetijamwal0911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Nanda |
| Designation |
Professor, Dept of Plastic Surgery |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital, Ansari nagar , new delhi
New Delhi
DELHI
110029
India |
| Phone |
9811209242 |
| Fax |
|
| Email |
deepaknanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeti Jamwal |
| Designation |
Senior Resident, Dept of Plastic Surgery |
| Affiliation |
VMMC and Safdarjung Hospital , Ansari nagar, New Delhi, 110029 |
| Address |
Department of burns and plastic surgery, First floor, Near Ward 22A, VMMC and Safdarjung Hospital, Ansari nagar , New Delhi
Department of burns and plastic surgery, First floor,Near Ward 22A
New Delhi
DELHI
110029
India |
| Phone |
8825067429 |
| Fax |
|
| Email |
neetijamwal0911@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, Ansari nagar ,New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
Department of Burns and Plastic Surgery |
| Address |
VMMC and Safdarjung Hospital, Ansari nagar, New Delhi, 110029 |
| 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 Neeti Jamwal |
VMMC and Safdarjung Hospital |
Department of Burns and Plastic surgery, VMMC and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029
New Delhi
DELHI |
8825067429
neetijamwal0911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S613||Open wound of other finger with damage to nail, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Finger tip injuries with soft tissue loss or exposed bone. |
|
| ExclusionCriteria |
| Details |
Patients with severely crushed finger tips |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional and aesthetic outcome |
1 , 2 and 4 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensation, Scar quality, Patient satisfaction |
1, 2 & 4 months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
27/11/2024 |
| 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="8"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [neetijamwal0911@gmail.com].
- For how long will this data be available start date provided 27-11-2024 and end date provided 27-04-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study will be performed on patients with finger tip injuries to study the effectiveness of bilayer dermal substitute in healing of wound followed by skin grafting. |