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CTRI Number  CTRI/2024/04/065325 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 01/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   DERMAL TEMPLATE USE FOR COMPLEX SOFT TISSUE DEFECTS- AN OBSERVATIONAL STUDY 
Scientific Title of Study   Usage Of Dermal Template for Reconstruction of Complex defects - a prospective observational study 
Trial Acronym  IDRT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Mookim 
Designation  registrar - plastic surgery 
Affiliation  KMC, MANIPAL 
Address  department of plastic surgery, KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  8340614229  
Fax    
Email  neha.mookim@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NC Sreekumar 
Designation  HOD- plastic surgery 
Affiliation  Kasturba medical college, MANIPAL 
Address  department of plastic surgery, KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861196174  
Fax    
Email  ncskumar2005@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Neha Mookim 
Designation  registrar - plastic surgery 
Affiliation  KMC, MANIPAL 
Address  department of plastic surgery, KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  8340614229  
Fax    
Email  neha.mookim@gmail.com  
 
Source of Monetary or Material Support  
Kasturba medical college, manipal. Department of plastic surgery, Manipal, Karnataka. 576104 
 
Primary Sponsor  
Name  Kasturba medical college 
Address  department of plastic surgery, Kasturba medical college Manipal 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 Neha Mookim  Kasturba medical college  department of plastic surgery, Kasturba medical college,Manipal
Udupi
KARNATAKA 
8340614229

neha.mookim@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba medical college  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 
 
Inclusion Criteria  
Age From  10.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients with complex defects, of any age group scheduled for plastic reconstruction.
Patient willing to follow protocol and giving positive consent.
ii. Patient profile includes:
a. Complex wounds which are non-graftable following serial dressings and thorough
surgical debridement.
b. Patients in whom multiple procedures were already done for trauma or where the
potential recipient vessels come within the trauma zone and not feasible for free
flap.
c. Patients in whom flap failure has occurred and simple methods of local tissue
transfer are not feasible.
d. Non infective wounds confirmed by gram staining and negative culture.
e. Areas where chances of post-operative scarring and /or contractures are greater,
owing to location, nature and etiology of injury.
 
 
ExclusionCriteria 
Details  Exclusion criteriai. Patients whose defect does not fit the criteria for dermal template
ii. Patients not giving positive consent or not following protocol
iii. Patients who are lost for follow up and who developed systemic infections will be
secondarily excluded.
iv. Deranged liver, kidney, lung, cardiac functions
v. Patients in whom waiting for 3 weeks before grafting is not feasible in case of IDRT®and
waiting for a minimum of 5 days not feasible in case of Matriderm® .
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rate of wound healing by area of defect covered after dermal template
reconstruction. 
1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients with IDRT failure.
ii. Proportion of patients needing other tissue transfer like flap in case of DRT failure
iii. Proportion of patients with immediate postoperative complications.
iv. Mean POSA score of patients at follow up.
v. Proportion of patients with poor functional outcomes and delayed postoperative
complications.
vi. Comparison of reconstruction outcomes of dermal template with flap reconstruction 
1 year 
 
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   N/A 
Date of First Enrollment (India)   15/04/2024 
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 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 - NO
Brief Summary  
When facing wound reconstruction, trauma and plastic surgeons have different options
to choose from, including skin grafting, local, regional, distant pedicled and free flaps,
and tissue expansion(1). Yet, Skin and soft tissue reconstruction remains a challenge
for plastic surgeons because of optimal aesthetic and functional outcomes.
For many centuries, skin grafts have been used to restore wound defects after trauma,
vascular disease, or cancer. However, availability of sufficient healthy skin can be an
issue, as well as the additional health risks associated with the procedure. The
deforming donor-site morbidity should also be considered when opting for skin grafting.
Disadvantages as such have led to innovations in skin tissue engineering.
Dermal template offers multiple advantages: It prepares the wound before the
positioning of a split-thickness skin graft. It is applicable in anatomical regions in which a
graft placement alone would not be preferred, such as on bone and tendon-exposed
areas, and improves the final outcome and feature of the scar. The positioning of the
matrix is relatively simple with a reduction of operating time. It allows the reduction of
inpatient time in the hospital and of surgical sequelae for the patient. However, Dermal
Templates could also be susceptible to infection, need a second procedure for the
coverage of the matrix with a skin graft, and have a relatively high cost compared to
autografts. Dermal templates are playing an increasingly important role in reconstruction
of complex defects, however there is a lack of evidence on their long-term outcomes. In
India, there is a lack of comprehensive studies detailing use and outcomes of dermal
templates .We aimed to review the use, outcomes and complications of IDRT within our
tertiary care centre, KMC, Manipal.
 
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