FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/078890 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A proof of concept study to check how safe and effective it is to use a spray gun to apply donor skin on the wound site 
Scientific Title of Study   A pilot observational study to evaluate the safety and efficacy in delivery of the donor skin segment using spray gun on the donor site 
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 Joseph Thomas 
Designation  Professor and Head 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Plastic Surgery Kasturba Hospital Kasturba Medical College Manipal Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9995783582  
Fax    
Email  joseph.plastic@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Jeffrey Pradeep Raj 
Designation  Associate Professor  
Affiliation  Kasturba Medical College Manipal 
Address  Division of Clinical Pharmacology Department of Pharmacology Ground floor Physiology Pharmacology Building Kasturba Medical College Manipal Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095464464  
Fax    
Email  jpraj.m07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jeffrey Pradeep Raj 
Designation  Associate Professor  
Affiliation  Kasturba Medical College Manipal 
Address  Division of Clinical Pharmacology Department of Pharmacology Ground floor Physiology Pharmacology Building Kasturba Medical College Manipal Madhav Nagar Manipal


KARNATAKA
576104
India 
Phone  8095464464  
Fax    
Email  jpraj.m07@gmail.com  
 
Source of Monetary or Material Support  
Pacify Medical Technologies Pvt Ltd. 105/2 Apurva Lake Complex, Near Annapurna Nagar, Adharwadi Chowk, Kalyan West, Thane, Maharashtra 421301  
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Madhav Nagar, Manipal, 576104 Karnataka 
Type of Sponsor  Private medical college 
 
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 
Dr Jeffrey Pradeep Raj  Kasturba Medical College Manipal  Department of Plastic Surgery Kasturba Hospital Kasturba Medical College Manipal Madhav Nagar, Manipal 576104
Udupi
KARNATAKA 		 8095464464

jpraj.m07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital Institutional Ethics Committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  SKin spray device  Apply donor skin to raw wound using skin spray device just once at the time of enrolment for a time period enough to cut the donor skin into small segements 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adults 18 years and above, any sex, willing to provide a written informed consent. [Women must be of no child-bearing potential or must have tested Negative for UPT]
Female participants can be considered not of childbearing potential only if they are with current bilateral tubal ligation or occlusion, or post-hysterectomy, or post-bilateral ovariectomy, or post-menopause.
2. Patients who are hospitalized and in whom Split thickness skin graft is harvested
3. The participant/ Legally acceptable representative is willing to give written informed consent
 
 
ExclusionCriteria 
Details  1. Patients who are critically ill
2. Documented skin disease at the time of enrollment as judged by the investigator
3. Treatment with immunosuppressants
4. Women who are pregnant or breast feeding
5. Inclusion in other ongoing study at present that would preclude the subject from participating in this study as judged by the investigator
6. Any other pathology that in the investigators opinion might interfere with the current study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a. Spray area to the harvested donor area ratio on the donor site
b. Area of epithelialization
c. Percentage of epithelialization measured with imaging software in order to compare with the initial wound area.
 		 Days 5 7 and 10 
 
Secondary Outcome  
Outcome  TimePoints 
a. Incidence of infection/ Discharge
b. Delay in healing due to complications
c. Number of dressings
d. Antiseptics, antibiotics and analgesics as well as skin-related medication doses required
e. Adverse device effect and serious adverse device effect (Infection
of the study site, Failure of the graft to grow, Pain and discomfort have already beenide ntified as anticipated effects in the Product Risk Management Record)
 		 Day 10 
VAS Pain score  Days 5 7 and 10 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) 06/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 study aims to evaluate the use of a spray gun to apply donor skin segments during skin grafting. It is a pilot interventional study designed to assess both the effectiveness and safety of this method for healing donor sites.

The primary goal is to see how well the spray gun promotes healing of the skin graft donor area. The secondary goal is to determine whether this method is safe for patients. The study is being conducted by the Departments of Plastic Surgery and Pharmacology at KMC Manipal.

Participants will include hospitalized adults undergoing split-thickness skin grafting. One half of their donor wound will be treated using the spray gun, while the other half will heal using traditional methods. The study will observe healing progress, pain levels, and any complications for up to 10 days.

The potential risks include graft failure, infections, and pain. However, the study aims to confirm the benefits of quicker healing and less pain when using this spray method compared to traditional grafting approaches. Ethical considerations and patient confidentiality are addressed, and compensation for any trial-related injury is provided.

The sample size is small (30 participants), and results from this pilot study could help fill research gaps on more efficient and safer skin grafting techniques.

 
Close