| CTRI Number |
CTRI/2026/03/106901 [Registered on: 25/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [WOUND THERAPY (DRESSING)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF EFFECTS OF THREE DIFFERENT MODALITIES FOR MANAGEMENT OF OPEN WOUNDS |
|
Scientific Title of Study
|
Comparative Evaluation of effects OF local Platelet-rich plasma, Ozone and Vacuum Assissted therapy in the management of Musculoskeletal soft tissue wounds: A Prospective Randomized 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 |
Dr Sachin Upadhyay |
| Designation |
Professor |
| Affiliation |
Department Of Orthopaedics Netaji Subhash Chandra Bose Medical College Jabalpur |
| Address |
Netaji Subhash Chandra Bose Medical College Jabalpur
622, SNEH NAGAR CHOWK, JABALPUR
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
9329078849 |
| Fax |
|
| Email |
drsachinupadhyay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aastha Johri |
| Designation |
Post Graduate Student |
| Affiliation |
DEPARTMENT OF ORTHOPAEDICS NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR |
| Address |
Hostel Number 7, Netaji Subhash Chandra Bose Medical College Jabalpur
Home Address: 15/114, HIG Duplex Vasundhara, Ghaziabad, Uttar Pradesh, PIN 201012, D/O Neeraj Johri
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
9999682717 |
| Fax |
|
| Email |
aasthajohri11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Upadhyay |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF ORTHOPAEDICS NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR |
| Address |
NETAJI SUBHASH CHANDRA BOSE MEDICAL COLLEGE JABALPUR
622, SNEH NAGAR CHOWK, JABALPUR
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
9329078849 |
| Fax |
|
| Email |
drsachinupadhyay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Local Research Advisory Committee, Multi-disciplinary Research Institute, Netaji Subhash Chandra Bose Medical College Jabalpur |
|
|
Primary Sponsor
|
| Name |
Local Research Advisory Committee Multidisciplinary Research Institute |
| Address |
Netaji Subhash Chandra Bose Medical College Jabalpur |
| 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 |
| Dr Sachin Upadhyay |
Netaji Subhash Chandra Bose Medical College Jabalpur |
Tilwara Road, Doctors Colony, Medical College Colony, Jabalpur, Madhya Pradesh
Jabalpur
MADHYA PRADESH |
9329078849
drsachinupadhyay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NSCB Medical College Jabalpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dressing with Ozone |
Ozone water is prepared using ozone generator and normal saline. Wound is washed on alternate days for 4-5 sittings |
| Intervention |
Dressing with Platelet rich plasma
|
Platelet rich plasma is prepared using a closed system and injected 1 cm from wound margin circumferenrially. Dressing is repeated every third day for 3-4 sittings. |
| Comparator Agent |
Vacuum-assissted Dressing |
VAC system is set up using locally available sponge, surgical drain and adhesive surgical drape. The setup is connected to maintain negative pressure of 125mmHg and dressing is changed every 48-72 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (18-60 years old) either sex having traumatic wounds (traumatic wounds associated with open fractures Gustilo Anderson Type I, II, IIIA and upto 15 cm diameter will be included. |
|
| ExclusionCriteria |
| Details |
Pre-existing osteomyelitis associated with wounds, Neurovascular deficit, Peripheral arterial disease related wounds, Uncontrolled blood sugar in patients with diabetes mellitus and patients with coagulopathies. Any chronic illnesses- HIV, Hepatitis B/C |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess lead time in healing of musculoskeletal wounds and determine significance of percentage area reduction as well as infection reduction among the three modalities |
Assessment to be done at 15 days, 1 month, 2 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased infection rates of wounds |
Wounds assessed at 15 days & 1 month & 2 months |
Decreased need of repeated debridement following adequate granulation tissue generation post reparative therapies being studied
|
Assessed at each dressing, 15 days, 1 month & 2 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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
|
Wounds can heal by primary closure, delayed primary closures or secondary intention. Various surgical methods have been developed to obtain coverage in difficult wounds, like skin grafting, local rotation flaps, and myocutaneous or fasciocutaneous tissue transfers. Non operative modalities such as PRP, NPT, Ozone therapy, hyperbaric oxygen is used to enhance wound coverage and accelerate the timeline to definitive management. The primary objective of the present study is to assess the potential therapeutic effects of and comparison among autologous platelet rich plasma and ozone therapy in the healing of musculoskeletal traumatic wounds.
Therapies like Platelet rich plasma and ozone therapy act as effective adjuncts to accelerate wound healing and augment conversion to definitive management by grafting or flaps or complete gradual closure. |