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CTRI Number  CTRI/2025/03/082920 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of early versus late excision and grafting in patients with acute burn 
Scientific Title of Study   A comparison of efficacy of early versus late excision and grafting in patients with acute burn- Open label randomised controlled 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  Akshat Kakani 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Burns and plastic surgery AIIMS, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9760984675  
Fax    
Email  akshatkakani1022@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Neeraj Rao 
Designation  Associate Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Burns and Plastic surgery, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8527619707  
Fax    
Email  neeraj.psurg@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Neeraj Rao 
Designation  Associate Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Burns and Plastic surgery, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8527619707  
Fax    
Email  neeraj.psurg@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
Institution Name: All India Institute of Medical Sciences, Rishikesh Department: Burns and Plastic Surgery Address: AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand, India – 249203  
 
Primary Sponsor  
Name  Dr Akshat Kakani 
Address  Department of Burns and Plastic surgery,AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand, India – 249203  
Type of Sponsor  Other [self] 
 
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 Neeraj Rao  Hospital  Department of Burns and Plastic Surgery, Room No. [014508], AIIMS Rishikesh, Uttarakhand, India – 249203
Dehradun
UTTARANCHAL 		 8527619707

neeraj.psurg@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Rishikesh Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T20-T25||Burns and corrosions of external body surface, specified by site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early excision and grafting in acute burns   Tangential excision of second degree deep to third degree acute burns along with resurfacing with thin split thickness skin graft within 7 days of burns 
Comparator Agent  Late excision and grafting in acute burns  Late tangential excision of acute burns along with resurfacing wounds with split thickness skin graft after 7 days of burns 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Total burns surface area 10-40 % second degree deep to third degree burns
Thermal, chemical, electric burns
Hemodynamic stability 
 
ExclusionCriteria 
Details  Known co morbidties ( Diabetes mellitus, Hypertension, Chronic kidney disease, Chronic liver failure)
Total burn surface area less than 10% and more than 40 %
Inhalational Injury
Additional trauma not getting pre anaesthesia clearance 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Compare SOFA score of burns in early vs late excision and grafting in acute burns  Baseline
2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To compare length of hospital stay in early vs late excision and grafting in acute burns   Day of admission to day of discharge 
To compare graft uptake on post operative day 7 in early vs late excision and grafting in acute burns   Post operative day 7  
To Compare mortality in early vs late excision and grafting in acute burns    
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   15/04/2025 
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="6"
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  

Title: A Comparison of Efficacy of Early vs Late Excision and Grafting in Patients with Acute Burns – Open Label Randomized Controlled Study
Candidate: Dr. Akshat Kakani, M.Ch (Plastic, Reconstructive, and Burns Surgery)
Institution: AIIMS Rishikesh

Introduction:

Burn injuries often require surgical intervention for optimal recovery. Early excision and grafting (EEG) have shown benefits in infection control, hospital stay reduction, and functional preservation. However, factors like late presentation and resource limitations hinder its widespread application. This study aims to compare EEG with late excision and grafting (LEG) in managing acute burns.

Objectives:

  • Primary Objective: Compare SOFA scores on day 10 between early and late excision groups.
  • Secondary Objectives:
    • Compare hospital stay duration.
    • Assess graft uptake on postoperative day 7.
    • Compare mortality rates between the two groups.

Methodology:

  • Study Design: Open-label randomized controlled trial
  • Setting: Department of Burns & Plastic Surgery, AIIMS Rishikesh
  • Duration: 18 months
  • Sample Size: 36 patients (18 in EEG group, 18 in LEG group)
  • Inclusion Criteria:
    • Patients aged 18–60 years
    • Total Body Surface Area (TBSA) burns between 10–40%
    • Thermal, electrical, or chemical burns
    • Hemodynamic stability
  • Exclusion Criteria:
    • Comorbid conditions (diabetes, hypertension, CKD, CLF)
    • Additional trauma preventing anesthesia clearance
    • Inhalational injuries
  • Interventions:
    • EEG Group: Surgery within 7 days of injury.
    • LEG Group: Initial wound care, surgery delayed until bed is suitable for grafting.
  • Randomization & Blinding: Participants will be randomly assigned using random envelope method. Open-label design.
  • Outcome Measures:
    • SOFA score on day 10
    • Length of hospital stay
    • Functional outcomes (clinical assessment)
    • Mortality rates
    • Graft uptake on postoperative day 7

Statistical Analysis:

  • Student t-test for SOFA score and hospital stay comparison.
  • Chi-square test for mortality rates.
  • Significance level: p < 0.05
  • Software: SPSS version 25

Ethical Considerations:

  • Institutional Ethics Committee (IEC) approval obtained.
  • Written informed consent from participants.
  • No financial burden on participants.

Conclusion:

This study aims to provide evidence on the efficacy of early excision and grafting in acute burns, potentially influencing standard burn management protocols.

 
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