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CTRI Number  CTRI/2026/01/101674 [Registered on: 20/01/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Other 
Public Title of Study   Comparison of treatment of pin tract infections with platelet rich fibrin versus daily dressing and antibiotics in external fixators 
Scientific Title of Study   Comparative evaluation of treatment of pin tract infections with platelet rich fibrin versus standard care in external fixators 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S SUDEESH 
Designation  Postgraduate resident 
Affiliation  Maulana Azad Medical College 
Address  A-4/232 2nd floor Paschim Vihar New delhi

Central
DELHI
110063
India 
Phone  9971986517  
Fax    
Email  sudeeshsubhash7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumit Sural 
Designation  Director Professor and Head of department 
Affiliation  Lok Nayak Hospital 
Address  Jawaharlal Nehru Marg, Delhi Gate, New Delhi

Central
DELHI
110002
India 
Phone  9999614742  
Fax    
Email  sumitsural@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumit Sural 
Designation  Director Professor and Head of department 
Affiliation  Lok Nayak Hospital 
Address  Jawaharlal Nehru Marg, Delhi Gate, New Delhi

Central
DELHI
110002
India 
Phone  9999614742  
Fax    
Email  sumitsural@hotmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  MAULANA AZAD MEDICAL COLLEGE 
Address  2, Bahadur shah zafar marg new delhi-110002 
Type of Sponsor  Government 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 
Dean Mamc  MAULANA AZAD MEDICAL COLLEGE  2, BAHADUR SHAH ZAFAR MARG, Delhi
Central
DELHI 
01123231871

lnh-msoffice@delhi.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Daily pintract dressing with betadine soaked gauze  Pin tract dressing for grade 1 pintract infections Oral antibiotics as rescue therapy in grade 2 pin tract infections if 2 PRF injections fail 
Intervention  PRF INJECTION  PLATELET RICH FIBRIN OBTAINED FROM CENTRIIFUGATON OF THE PATIENTS BLOOD 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 18 to 65
Patients being treated by external fixators (Tubular fixators with schanz screws, ring fixators with kirschner wires of hybrid fixation and schanz screws)
Grades -2 and 1 of pin tract infections as per Checketts and Otterburn classification 
 
ExclusionCriteria 
Details  1. Platelet count less than 1 lakhs.
2. Patients on any medication or having a disease that alters the platelet count or the function 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Healing of grade-2 pin tract infections assessed by decrease in pain, discharge, redness or worsening assessed by loosening of pins  Day- 3-5 
 
Secondary Outcome  
Outcome  TimePoints 
Healing of grade 1 pin tract infections assessed by decrease in discharge, redness or need for oral antibiotics  Day-3-5  
 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/02/2026 
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="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  



Patients with external fixator applied, with infected pin tract will be participating in this study in which after fulfilling the inclusion criteria patients will undergo a history and physical examination by clinicians. Patients will be allotted one of the two groups according to the grade of infection (Grade-1 not responding to treatment and Grade-2). 

If patient has grade-1 pin tract infections they will be subjected to 1 week of daily dressing with povidone iodine as per standard treatment guidelines, if the infection is not responding to treatment, patient will be recruited in the study. Randomization will be done into two groups (Group S and Group PRF). If patient is in the Group PRF then they will receive iPRF and/or PRF gel injection after curettage, if patient is  in Group S they will receive standard treatment. While all grade 2 pin site infections will be subjected to randomization in to two groups. Group S will receive standard treatment with antibiotics and those in group PRF will be managed by removal of any crust or any discharge followed by liquid PRF infiltration around the infected pin site. The pin site will be reassessed after 3-5 days and if required, another injection of liquid PRF will be injected. If there is worsening, rescue oral antibiotics will be started. Patients are not allowed to request for change of group during the study. Around 10-20 ml of blood will be taken from the patient which might cause some discomfort due to needle prick and which will be used to make platelet rich fibrin using a centrifuge, This PRF will be injected to infected pin tract in the study group. Patient will be assessed post-injection clinically using Visual analogue scale. If the patient is willing to participate in the study then they have to undergo a follow up of at least 3-7 days. At each follow up patient will be assessed clinically using VAS.

 
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