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CTRI Number  CTRI/2024/04/065005 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Development of biological dressing for wound management of acute burns and trauma 
Scientific Title of Study   Development of cell-laden 3D scaffold for wound management of acute burns and trauma 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mathew Peter 
Designation  Assistant Professor 
Affiliation  Manipal Institute of Technology, Manipal 
Address  Department of biomedical Engineering, Manipal Institute of Technology, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  9322428766  
Fax    
Email  mathew.peter@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Mathew Peter 
Designation  Assistant Professor 
Affiliation  Manipal Institute of Technology, Manipal 
Address  Department of biomedical Engineering, Manipal Institute of Technology, Manipal 576104


KARNATAKA
576104
India 
Phone  9322428766  
Fax    
Email  mathew.peter@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mathew Peter 
Designation  Assistant Professor 
Affiliation  Manipal Institute of Technology, Manipal 
Address  Department of biomedical Engineering, Manipal Institute of Technology, Manipal 576104


KARNATAKA
576104
India 
Phone  9322428766  
Fax    
Email  mathew.peter@manipal.edu  
 
Source of Monetary or Material Support  
Ktech Elevate Grant 2023 Address: 85, Kengal Hanumanthaiah Rd, NGO Colony, Sudhama Nagar, Bengaluru, Karnataka 560027 
MSME Hackathan Grant 2022 Address: Room No 468 C, Udyog Bhawan, Rafi Marg, New Delhi - 110011 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal  
Address  Tiger Circle Road, Madhav Nagar Eshwar Nagar Manipal Karnataka 576104 
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 Mathew Peter  Manipal Institute of Technology Manipal  Department of Biomedical Engineering, Manipal Institute of Technology MAHE
Udupi
KARNATAKA 		 9322428766

mathew.peter@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College/Kasturba Hospital Institutional Ethical Committee (KMC/KH IEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: L987||Excessive and redundant skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing liposuction or C-section as a delivery or treatment for various diseases and non-disease conditions chiefly as a contouring procedure. The umbilical cord or the liposuction aspirate is the discarded waste product of the procedure that will be used in study. 
 
ExclusionCriteria 
Details  Patients with blood related disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Samples from 20 patients undergoing plastic surgery (liposuction) or C-section delivery will be recruited for the study   24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Blood sample procurement from patient for phenotype & genotype characterization  24 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/05/2024 
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 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   In our project, we will focus on developing a wound dressing with allogeneic mesenchymal stem cell-laden biocompatible hydrogel that has the potential to incorporate onto the body and accelerate and optimise healing and even potentially become a substitute for autologous skin grafts. The innovation in this project relies on the development of a hydrogel sheet containing cell-laden allogenic Mesenchymal Stem Cells to promote active wound healing and wound closure in traumatic wound. Hydrogel provides a moist environment around the wound site which is ideal for extensive healing for both exudating and necrotic wounds. The role of Mesenchymal Stem Cells in wound healing has a promising outcome and has been researched extensively in the last few decades. Moreover, allogeneic-MSCs have been shown to evade immune rejection by the host as they express very low levels of MHC class I, no MHC class II and do not induce activation of allogeneic lymphocytes. It also has greater regenerative and wound closure properties than other skin cell types like fibroblast and keratinocyte by inducing re-epithelisation and angiogenesis. 
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