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CTRI Number  CTRI/2025/02/080106 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study to see the effect of radiotherapy in preventing recurrence of keloids after surgical excision 
Scientific Title of Study   Outcome analysis of adjuvant radiotherapy after surgical excision in keloids  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jiten Kumar Mishra  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences, Raipur  
Address  Burns and Plastic Surgery Department, AIIMS, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9437616743  
Fax    
Email  mishra.jitenkumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jiten Kumar Mishra  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences, Raipur  
Address  Burns and Plastic Surgery Department, AIIMS, Raipur


CHHATTISGARH
492099
India 
Phone  9437616743  
Fax    
Email  mishra.jitenkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jiten Kumar Mishra  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences, Raipur  
Address  Burns and Plastic Surgery Department, AIIMS, Raipur


CHHATTISGARH
492099
India 
Phone  9437616743  
Fax    
Email  mishra.jitenkumar@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Raipur  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raipur  
Address  Burns and Plastic Surgery Department, AIIMS Raipur, Raipur, Chhattisgarh - 492099 
Type of Sponsor  Research institution and hospital 
 
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 Jiten Kumar Mishra  All India Institute of Medical Sciences, Raipur   D-block, 1st floor, Burns and Plastic Surgery Department
Raipur
CHHATTISGARH 		 09437616743

mishra.jitenkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients presenting with keloid in any part of the body that are planned for excision followed by primary closure or flap closure where no residual open wound is left after excision 
 
ExclusionCriteria 
Details  i. Uncontrolled diabetes
ii. Uncontrolled hypertension
iii. Pregnancy
iv. Connective tissue disorder
v. Prior radiotherapy to same part
vi. Patients in whom after keloid excision the wound is not primarily closed or grafted are excluded as adjuvant radiation cannot be applied over open wound 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To analyze recurrence of keloid after postoperative radiotherapy   Immediate post operative asessment, suture removal at day 14, follow up at 3 months, 6 months, 9 months and 12 months from surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of complication in post operative patients including wound dehiscence , infection , erythema
Patient and observer evaluation using the Patient and Observer Scar Assessment Scale (POSAS) 		 3 monthly follow up for 1 year 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   28/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   Keloids are abnormal scars that occur due to an imbalance between an increased synthesis of collagen and extracellular matrix and decreased degradation of these products. When treated inadequately, it leads to excessive scar formation that is a physical and emotional distress. Dysregulation of collagen remodeling leads to excessive scar formation and hence disfiguration. They appear slowly over months and progress beyond the confines of the original wound and do not regress spontaneously. Several treatment modalities like interferons, intralesional steroid injections, cryotherapy, laser therapy, silicone gel sheets have been used in the management of keloids. However a high recurrence rates (>50%) persists with these approaches. Surgical excision alone is ineffective and additional treatment modalities are needed and radiotherapy has been used as part of this combination therapy. Adjuvant post operative radiotherapy aims to prevent local recurrence, by targeting immature fibroblasts resulting in suppression of their proliferation, inhibition of collagen synthesis and thereby reducing the recurrence of keloids. There are not enough studies giving a standard protocol for post-operative radiotherapy. In our study, the patient after surgical excision of keloid will be given low dose radiation of 12Gy in 3 fractions over 3 days, starting within 24 hours of the excision. The patient will be followed-up to assess the recurrence of keloids, wound complications such as infection, dehiscence or erythema, and scar assessment using the Patient and observer scar assessment scale (POSAS) in a 3-monthly interval over a duration of 12 months.  
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