| 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
|
|
|
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
|
|
|
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
|
|
|
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. |