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Clinical Trials/CTRI/2024/05/068198
CTRI/2024/05/068198
Not yet recruiting
Not Applicable

A Comparative Study On Efficacy Of Injectable Platelet Rich Fibrin (i-PRF) And Platelet Rich Plasma (PRP) In Facial Scars - A Triple Blinded Randomized Clinical Trail.

Anil Neerukonda Institute of Dental Sciences1 site in 1 country30 target enrollmentStarted: June 15, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Anil Neerukonda Institute of Dental Sciences
Enrollment
30
Locations
1
Primary Endpoint
surface area of the scar

Overview

Brief Summary

  1. Aim of this study is to compare the efficacy between Injectable Platelet-Rich Fibrin (i-PRF) and Platelet-Rich Plasma (PRP) in the treatment of Facial Scars. Patients who report with chief complaint of facial scar to the Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam. Careful evaluation & selection of participants. Written Informed Consent will be taken from selected participants & Preoperative Patient and Observer Scar Assessment Scale (POSAS) will be takenrespectively. The co- investigator will be helping in blinding and allocation concealment. The participants will be randomly assigned to Group A & Group B. Both the Principal Investigator and Participant will be blinded. The Co-investigator will be helping with randomization, blinding and Allocation concealment. The Evaluator, who is blinded, will assess Postoperative outcomes one month after the last session in all the participants from both the groups by Patient and Observer Scar Assessment Scale (POSAS). The collected data will be consolidated and statistically analyzed.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Scars secondary to surgical incision and trauma.
  • Scars involving head and neck region.
  • Patients willing to participate in the study.

Exclusion Criteria

  • Scars secondary to burns, acne.
  • Scars that received any previous revision/treatment.
  • Patients with history keloid tendency, any active skin/systemic conditions, immunosuppression, bleeding and clotting disorders, pregnancy.

Outcomes

Primary Outcomes

surface area of the scar

Time Frame: 1 month

Secondary Outcomes

  • pigmentation and texture(1 month)

Investigators

Sponsor
Anil Neerukonda Institute of Dental Sciences
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Narasimhadevara Santha Lakshmi Pratyusha

Anil Neerukonda Institute Of Dental Sciences

Study Sites (1)

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