| CTRI Number |
CTRI/2026/02/103371 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare how effective a novel skin grafting technique using a spray gun is to conventional mesh grafting
on full thickness wounds |
|
Scientific Title of Study
|
Outcomes of morcellised skin grafting versus conventional mesh grafting
on full thickness wounds: An intrapatient 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 |
Tinku Antony |
| Designation |
Assistant professor |
| Affiliation |
Command Hospital AirForce Bangalore |
| Address |
Surgical Division
Command Hospital AirForce
Agram Post
Bangalore
560007
Bangalore
KARNATAKA
60007
India |
| Phone |
8527040675 |
| Fax |
|
| Email |
antonytinku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tinku Antony |
| Designation |
Assistant professor |
| Affiliation |
Command Hospital AirForce Bangalore |
| Address |
Surgical Division
Command Hospital AirForce
Agram Post
Bangalore
560007
Bangalore
KARNATAKA
60007
India |
| Phone |
8527040675 |
| Fax |
|
| Email |
antonytinku@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tinku Antony |
| Designation |
Assistant professor |
| Affiliation |
Command Hospital AirForce Bangalore |
| Address |
Surgical Division
Command Hospital AirForce
Agram Post
Bangalore
560007
Bangalore
KARNATAKA
60007
India |
| Phone |
8527040675 |
| Fax |
|
| Email |
antonytinku@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Defence Innovation Organisation Under aegis of ministry of defence |
| Address |
Surgical Division
Command Hospital AirForce
Agram Post
HAL Old Airport road
Bangalore 560007
Karnataka |
| Type of Sponsor |
Government funding agency |
|
|
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 Tinku Antony |
Command Hospital AirForce |
Room number 1, Surgical Division
Command Hospital AirForce Bangalore
HAL Old Airport road
Agram Post
560007
Bangalore
KARNATAKA |
8527040675
antonytinku@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital AirForce Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L97||Non-pressure chronic ulcer of lower limb, not elsewhere classified, (2) ICD-10 Condition: L984||Non-pressure chronic ulcer of skin, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Meshed skin grafting |
Comparator arm will receive Meshed skin grafting which will be applied onto the wound |
| Intervention |
Morcellised skin grafting |
Intervention arm will receive Morcellised skin which will be sprayed onto the wound with a proprietary spray gun. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 65 years
all genders
patients who are hospitalised with wounds requiring split skin grafting |
|
| ExclusionCriteria |
| Details |
Critically ill patients
Presence of skin disease at the time of enrolment
Treatment with immunosuppressants
Pregnant/lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare graft take after morcellised skin grafting and conventional
mesh grafting |
Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare epithelisation time
|
days
5, 7, 14, 21, and 28, 60 postoperatively |
| Donor skin requirement |
Ratio of the grafted area to the harvested donor
skin area will be used to calculate to compare spray graft -to-wound area
(SWA) and meshed graft-to-wound area (MWA) calculated intraop |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="10"
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 - 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [antonytinku@gmail.com].
- For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Skin loss due to large wounds pose considerable surgical challenge especially in resource poor settings, where access to advanced wound management tools may be limited. Traditional split thickness skin grafting is widely used however poses a challenge when donor skin is scarce. Advances in surgical innovation have led to new graft delivery systems including micro grafting and spray assisted grafting These methods aims to optimise the use of autologous skin by increasing its coverage potential, while maintaining high cell viability The spray gun developed by pacify technologies is one such innovation designed to facilitate uniform delivery of minced skin particles over wound beds. This study will assess comparative performance of spray gun against conventional method of meshed skin grafting.
|