| CTRI Number |
CTRI/2024/07/071302 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| 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
|
Evaluation of advanced dressing procedure in comparison with the standard dressing procedure for Healing long-term Wounds |
|
Scientific Title of Study
|
A Comparative Study on the Efficacy of Advanced PRF (A-PRF) versus Standard PRF (S-PRF) in treating Chronic Wounds, An Open-Label, Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SDAP-032/01 version 01 Dated 06-05-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranganath V S |
| Designation |
Medical Director Consultant Plastic Surgeon |
| Affiliation |
Surgiderma Hospital |
| Address |
Department of Dermatology, 2nd Floor, Consultant Room, Surgiderma Hospital - Skin Hair Laser Plastic Surgery
No. 5AC, 927, 5th A Cross Rd,
HRBR Layout 1st Block, Babusapalya, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
8050620427 |
| Fax |
|
| Email |
ranganath.vitlapur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditya V |
| Designation |
Assistant professor |
| Affiliation |
Gautham College of Pharmacy |
| Address |
Department of Pharmacy Practice, 3rd floor, Room No.3, Gautham College of Pharmacy
Bhuvaneshwari nagar, R. T. Nagar post.
Bangalore
KARNATAKA
560032
India |
| Phone |
9008427619 |
| Fax |
|
| Email |
adithyavh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jasmine S |
| Designation |
Research Coordinator |
| Affiliation |
Gautham College of Pharmacy |
| Address |
Department of Pharmacy Practice, 3rd floor, Room No.3,Gautham College of Pharmacy
Bhuvaneshwari nagar, R. T. Nagar post.
Bangalore
KARNATAKA
560032
India |
| Phone |
9380717112 |
| Fax |
|
| Email |
jasminesarwan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surgiderma Hospital - Skin Hair Laser Plastic Surgery No. 5AC 927, 5th A Cross Rd, HRBR Layout, 1st Block, Babusapalya, Kalyan Nagar, Bengaluru, Karnataka, India, 560043. |
|
|
Primary Sponsor
|
| Name |
Dr Ranganath V S |
| Address |
Surgiderma Hospital - Skin Hair Laser Plastic Surgery
No. 5AC, 927, 5th A Cross Rd,
HRBR Layout 1st Block, Babusapalya, Kalyan Nagar |
| Type of Sponsor |
Other [Self] |
|
|
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 Ranganath V S |
Surgiderma Hospital - Skin Hair Laser Plastic Surgery |
Department of Dermatology, 2nd Floor, Consultant Room, No. 5AC, 927, 5th A Cross Rd,
HRBR Layout 1st Block, Babusapalya, Kalyan Nagar
Bangalore
KARNATAKA |
8050620427
ranganath.vitlapur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PRANAV DIABETES CENTER ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Advanced Platelet-Rich Fibrin (A-PRF) |
15ml of venous blood will be drawn from the patients arm and centrifuged at 1500 rpm for 14 minutes to obtain A-PRF clots. Dressing procedure will be done using A-PRF clots once weekly for 4 weeks. |
| Comparator Agent |
Standard Platelet-Rich Fibrin (S-PRF) |
15ml of venous blood will be drawn from the patients arm and centrifuged at 2700 rpm for 12 minutes to obtain S-PRF clots. Dressing procedure will be done using S-PRF clots once weekly for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants with chronic wound for more than six weeks and have failed to heal by conventional treatments.
Wound size of less than 20cm2.
Both male and female participants.
Age 20 years or older.
Have a normal platelet count in range of 1,50,000- 4,50,000 cells/mm3.
Have a normal PT time: 11- 16 seconds.
Ability to provide informed consent or have a legally authorized representative able to provide consent on behalf of the participant.
Willingness to comply with study procedures and follow-up visits.
Adequate understanding of the study requirements and ability to communicate with study personnel. |
|
| ExclusionCriteria |
| Details |
Presence of an active infection at the ulcer site.
Patients on anticoagulants (warfarin, heparin).
Pregnant and lactating women.
Patients suffering from leukaemia, septicaemia, impaired platelet function or other haematological disorders.
Patients with hypoproteinaemia.
Patients taking long term steroid containing drugs or using steroid ointments on wounds. |
|
|
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 |
| Change in mean size reduction of wound area from the baseline wound size. |
Evaluation of wound size at week 2 and week 4 from baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participants Quality of Life using Wound QoL-17 Questionnaire. |
Evaluation of Participants Quality of Life at week 2 and week 4 from baseline. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/08/2024 |
| 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="4"
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
|
Advanced Platelet rich fibrin (A-PRF) represents a refinement of traditional PRF preparation techniques, aiming to enhance the concentration and bioactivity of growth factors within the fibrin matrix. This modification is hypothesised to improve the therapeutic potential of A-PRF in wound healing compared to Standard PRF (S-PRF). While both A-PRF and S-PRF have shown promise in wound healing, there remains a paucity of comparative studies evaluating their efficacy specifically in the context of chronic wound. This is an Open-Label Randomised Controlled Trial (RCT) comparing the efficacy of A-PRF versus S-PRF in treating chronic wounds. This research is warranted to provide evidence-based guidance for clinical practice and holds significant implications for advancing the field of wound care by elucidating the potential benefits of A-PRF over S-PRF in chronic wound management. |