CTRI Number |
CTRI/2025/05/087166 [Registered on: 20/05/2025] Trial Registered Prospectively |
Last Modified On: |
20/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Reconstruction of dorsal foot defects: Comparing Skin Substitutes with Natural Tissue Flaps |
Scientific Title of Study
|
Comparative analysis between dermal substitutes and free fasciocutaneous flaps in reconstruction of dorsal foot defects - A Randomized Controlled Trail. |
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 Deepti Katrolia |
Designation |
Associate Professor |
Affiliation |
AIIMS JODHPUR |
Address |
Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan
Jodhpur RAJASTHAN 342005 India |
Phone |
8587997469 |
Fax |
|
Email |
deepti.katrolia@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Deepti Katrolia |
Designation |
Associate Professor |
Affiliation |
AIIMS JODHPUR |
Address |
Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan
Jodhpur RAJASTHAN 342005 India |
Phone |
8587997469 |
Fax |
|
Email |
deepti.katrolia@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Praveen Kumar N |
Designation |
Senior Resident |
Affiliation |
AIIMS JODHPUR |
Address |
Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan
Jodhpur RAJASTHAN 342005 India |
Phone |
8792698650 |
Fax |
|
Email |
praveenkumar19934@gmail.com |
|
Source of Monetary or Material Support
|
All india institute of medical sciences jodhpur |
|
Primary Sponsor
|
Name |
All india institute of medical sciences jodhpur |
Address |
Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan 342005 |
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 Praveen Kumar N |
All India Institute of Medical Sciences |
Department of Burns and Plastic surgery ,All India Institute of Medical Sciences , Basni,jodhpur , Rajasthan 342005 Jodhpur RAJASTHAN |
8792698650
praveenkumar19934@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
All india institute of medical sciences , jodhpur Institutional Ethics Committee( Clinical Trial) |
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 |
Dermal substitutes |
selected patients will undergo Dermal Substitute application over raw area of dorsum of foot along with negative pressure wound therapy and after post operative 21 days , patient will undergo delamination of superficial layer of dermal substitute with Split thickness skin grafting over raw area and patient will be assesed in immediate post operative period at 3 months and 6 months post operatively for aesthetic and functional outcomes |
Comparator Agent |
Free fasciocutaneous flaps |
selected paitents will undergo free fasciocutaneous flap surgery for raw area over dorsum of foot and patient will be assessed in immediate post operative period at 3 months and 6 months post operatively for aesthetic and functional outcomes. |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
All patients undergoing dermal substitute application and free fasciocutaneous flaps for reconstruction of dorsal foot defects due to trauma ,infections post oncologic resection , diabetes and ulcers size more and 3cmsq and below 25cmsq |
|
ExclusionCriteria |
Details |
Patients with peripheral vascular disease for limb defects , unfit for prolonged surgeries and patients with psychiatric disorders |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To assess functional recovery and aesthetic outcome in immediate and late post- operative groups operative period in both the groups |
Immediate , At 3 weeks and monthly for 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate healing time, sensation recovery, complication rates,duration of hospital stay and cost effectiveness in both the groups |
Immediate , At 3 weeks and monthly for 6 months |
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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)
|
16/06/2025 |
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="1" Months="6" Days="0" |
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 - NO
|
Brief Summary
|
A prospective randomized controlled trial will be conducted to compare the functional, aesthetic, and psychosocial outcomes of dermal substitutes versus free fasciocutaneous flaps in the reconstruction of dorsal foot defects. Patients will be randomly allocated into two groups using a computer-generated randomization sequence. Outcome measures will be assessed in the immediate postoperative period, at 3 weeks, and at monthly intervals for a total duration of 6 months. |