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CTRI Number  CTRI/2021/01/030558 [Registered on: 19/01/2021] Trial Registered Prospectively
Last Modified On: 18/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of use of human donor skin grafts in treating burn wounds. 
Scientific Title of Study   Evaluation of efficacy of human skin allografts in healing of partial thickness burn wounds. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gurlinka Srihari 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Surgery 3rd Floor Smt. Sharadha Madhav Pai OPD Block Kasturba Hospital Manipal Udupi District

Udupi
KARNATAKA
576104
India 
Phone  8500816080  
Fax    
Email  gurlinka.hari11@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sreekumar N C 
Designation  Professor of Plastic Surgery 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Plastic Surgery 2nd Floor Old OPD Block Kasturba Hospital Manipal Udupi District

Udupi
KARNATAKA
576104
India 
Phone  9809353454  
Fax    
Email  ncs.kumar@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Annappa Kudva 
Designation  Professor of Surgery 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Surgery 3rd Floor Smt. Sharadha Madhav Pai OPD Block Kasturba Hospital Manipal Udupi District

Udupi
KARNATAKA
576104
India 
Phone  9448857394  
Fax    
Email  annappa.kudva@manipal.edu  
 
Source of Monetary or Material Support  
Department of Plastic Surgery, Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Dr Annappa Kudva 
Address  Professor of Surgery Department of General Surgery 3rd Floor Smt. Sharadha Madhav Pai OPD Block Kasturba Hospital, Manipal Udupi District 
Type of Sponsor  Other [Investigator Initiated Study] 
 
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 Sreekumar NC  Kasturba Hospital, Manipal  Burns HDU Ground Floor Old IP Block Kasturba Hospital Manipal 576 104
Udupi
KARNATAKA 
9809353454

ncs.kumar@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T300||Burn of unspecified body region, unspecified degree,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with Partial thickness burns undergoing tangential excision (Debridement) and allografting of burn wounds after hemodynamic stability in the department of Plastic Surgery 
 
ExclusionCriteria 
Details  1)Patients on Medications negatively affecting wound healing such as Corticosteroids, Chemotherapeutic agents.

2)Age > 75years, <1 year

3)Chemical induced Burns, Radiation Burns, Cold Burns, Immunocompromised patients and patient with collagen disorders. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of human skin allograft in the wound healing of partial thickness burn wounds as a definitive dressing.

Wound is considered healing based on either of the following criteria
1.Peeling of allograft with evidence of epithelization of surface underneath.
2.Grafted area appears dry or the secretions from the grafted area are decreased when inspected on POD 4, POD 10, POD 15 and POD 21.
 
Upto POD 21 
 
Secondary Outcome  
Outcome  TimePoints 
Allograft rejection and scar  Upto 3 months after allograft application 
 
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)   25/01/2021 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  Peers involved in the manuscript review for publication and any regulatory authority

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  The data will be sent on written request by the Editor of the Journal or Head of the regulatory authority

  6. For how long will this data be available start date provided 25-01-2021 and end date provided 25-01-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Informed consent will be obtained from all participants before enrolling into the study. Data regarding time of sustainment of burns and cause of burns will be recorded. Information regarding pre-existing illness/comorbidities will be collected. Alcohol consumption and Tobacco usage history will be collected. Area of the burns is measured using Modified Lund and Browder chart and Palmar method, and depth of the wound will be mapped pictorially. Area of the Partial thickness burn wound Allografted will be measured postoperatively. After allografting wound will be evaluated on POD 4, POD 10, POD 15 and POD 21 or on the day of discharge (which one of the either is the earliest) to look for healing. Area of the wound  taken up for early Auto grafting, if the wound is considered non healing after Allografting, will be measured and on which postoperative day after allografting  the decision made by the treating unit and the POD on which the wound is Autografted will be noted. Data regarding lab parameters such as Haemoglobin, Serum electrolytes, Serum Total Proteins, Serum albumin and Blood culture, wound culture sensitivity reports will be collected during the course of study period. Body weight of the patient will be measured at the time of admission and weekly after Allografting. Pain scoring will be done, from age 10 yrs to 75 yrs, at the time of admission on POD 4, POD 10, POD 15 and POD 21 or on the day of discharge (which one of the either is the earliest). Data regarding blood product transfusions, Albumin infusion and electrolyte imbalance corrections (post Allografting) will be collected. Information regarding the illness/Disease/comorbidities found on evaluation by the treating unit during the course of study will be collected. Percentage area of the allografted wound healed will be measured at the time of discharge. Feedback will be collected on follow up regarding nature of scar after 1week, 1month, 2months, 3 months, after discharge. Statistics will be provided at the end of study.


 
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