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CTRI Number  CTRI/2025/08/093814 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Spray Gun Technique for Skin Grafting on Post-Traumatic Wounds: A Pilot Study 
Scientific Title of Study   Skin Graft Harvesting and Application by indigenously developed Spray Gun technique on Post Traumatic Raw areas: A Pilot 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  Dr Sushma Sagar 
Designation  Professor 
Affiliation  JPNATC AIIMS 
Address  Room 229 second floor Division of Trauma Surgery and Critical Care JPNATC AIIMS

New Delhi
DELHI
110029
India 
Phone  9868397702  
Fax    
Email  sagar.sushma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sushma Sagar 
Designation  Professor 
Affiliation  JPNATC AIIMS 
Address  Room 229 second floor Division of Trauma Surgery and Critical Care JPNATC AIIMS

New Delhi
DELHI
110029
India 
Phone  9868397702  
Fax    
Email  sagar.sushma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sushma Sagar 
Designation  Professor 
Affiliation  JPNATC AIIMS 
Address  Room 229 second floor Division of Trauma Surgery and Critical Care JPNATC AIIMS

New Delhi
DELHI
110029
India 
Phone  9868397702  
Fax    
Email  sagar.sushma@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI Pacify Medical Technologies Pvt. Ltd. It is certified under ISO 13485:2016. 
 
Primary Sponsor  
Name  Pacify Medical Technologies Private Limited 
Address  6007, Rahul Bajaj TechnologyInnovation centre, IIT Bombay Academic area, YP Road, Powai, Mumbai-400076, Maharashtra, India 
Type of Sponsor  Other [Private company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Sushma Sagar  JPN APEX TRAUMA CENTRE  ALL INDIA INSTITUTE OF MEDICAL SCIENCES New Delhi
South
DELHI 
011 26731118

sagar.sushma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee  Submittted/Under Review 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T798||Other early complications of trauma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intra subject control  Patient will be their own controls 
Intervention  Spray Gun  Minced Micrograft using spray gun for management of raw areas following trauma for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients who are hospitalized and in whom Split thickness skin graft is harvested
2 Patients presenting exclusively with traumatic wounds.  
 
ExclusionCriteria 
Details  1 Critically ill patients
2 Presence of skin disease at the time of enrolment
3 Treatment with immunosuppressants
4 Pregnant/lactating women
5 Concurrent participation in other studies
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a Spray-to-Donor Area Ratio: Ratio of the sprayed area to the harvested donor skin area applied to the wound site.
b Graft Take Rate: Percentage of graft uptake, defined as the ratio of epithelialized graft area to the total grafted area, assessed on postoperative Day 10
c Epithelialized Area: Measurement of the area of epithelialization on Days 5, 7, and 10 postoperatively.
d Percentage of Epithelialization: Quantification of epithelialization on Day 10 using imaging software, expressed as a percentage of the initial wound area
 
Follow up at day 3,day 5, day7,day10, day14 and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
a Incidence of Infection/Discharge: Presence of infection or wound discharge up to Day 10 or until patient discharge, whichever occurs earlier.
b Delayed Healing Due to Complications: Occurrence of delayed wound healing attributable to any complications observed up to Day 10 or until discharge.
c Frequency of Dressing Changes: Total number of dressing applications required up to Day 10 or until discharge.
 
Follow up at day 3,day 5, day7,day10, day14 and 6 weeks 
 
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   N/A 
Date of First Enrollment (India)   08/09/2025 
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="0"
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  

This prospective, interventional pilot study will investigate the effectiveness of spray gun-assisted autologous skin grafting in accelerating healing in traumatic wounds. With the increasing burden of complex traumatic injuries in low-resource settings, there will be a pressing need to enhance wound healing outcomes while minimizing donor site morbidity. The spray gun method will allow uniform distribution of minced skin grafts, enabling significant expansion of donor skin and promoting early epithelialization. The study will be conducted at AIIMS Trauma Centre and will enroll 30 adult patients who will meet the inclusion criteria for split-thickness skin grafting (STSG). Each patient will serve as their own control. One half of the STSG donor site will be treated with the spray technique, while the other half will receive standard care. The primary endpoints will include graft take percentage, degree and rate of epithelialization, and pain assessment. Secondary parameters will include infection rates, dressing frequency, and analgesic requirements.

 
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