| CTRI Number |
CTRI/2025/07/092018 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Aesthetic and functional outcomes of treatment in acute fingertip injury |
|
Scientific Title of Study
|
Aesthetic and functional outcomes of surgical intervention in acute fingertip injury: A prospective study in tertiary care centre |
| 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 Varsha Kalyanpur |
| Designation |
Mch plastic surgery resident |
| Affiliation |
|
| Address |
Department of plastic and reconstructive surgery ,Kle s jawaharlal Nehru medical College nehrunagar belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
varsha.vsk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D U Rajput |
| Designation |
HOD and Professor |
| Affiliation |
|
| Address |
Kle s jawaharlal Nehru medical College nehrunagar belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
docrajput@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Kalyanpur |
| Designation |
Mch plastic surgery resident |
| Affiliation |
Kles Jawaharlal Nehru medical College |
| Address |
102 rao tower urwa longlane mangalore 102,rao towers
Belgaum Karnataka India
Belgaum
KARNATAKA
575006
India |
| Phone |
07259107349 |
| Fax |
|
| Email |
varsha.vsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kles Jawaharlal Nehru medical College |
|
|
Primary Sponsor
|
| Name |
Kles Jawaharlal Nehru Medical College |
| Address |
Department of plastic and reconstruction surgery ,Belagavi,karnataka,India, 590010 |
| Type of Sponsor |
Private 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 Varsha Kalyanpur |
Kles Jawaharlal Nehru medical College |
department of plastic and reconstruction surgery,nehru nagar belagavi 590001
Belgaum
KARNATAKA |
7259107349
varsha.vsk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jnmc institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S411||Open wound of upper arm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Thenar flap cover |
Flap to cover finger tip injury |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Acute finger tip injury |
|
| ExclusionCriteria |
| Details |
Multiple injuries in same finger |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Satisfaction of patient
2 point discrimination
|
Immediately post op
And after 2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Color match
Donor site morbidity |
After 2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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)
|
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
|
Demographic details of patients collected Will undergo procedure Followed up post op and after 2 months for functional and aesthetic outcomes |