RecruitingNot ApplicableNCT06281483

PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers

Efficacy of Platelet-rich Plasma Versus Platelet-rich Fibrin Versus Conventional Treatment in Chronic Non-healing Skin Ulcers: a Comparative Study


Sponsor

Kafrelsheikh University

Enrollment

36 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

  • Patients presenting with cutaneous ulcers greater than six weeks of duration and a size ranging between 0.5 and 10 cm, having a normal platelet count and hemoglobin >10 gm%.

Exclusion Criteria4

  • Patients with known bleeding disorders, and/or on oral anticoagulant therapy, uncontrolled diabetes, proven malignancy.
  • Patients who are pregnant or lactating.
  • Patients with actively infected ulcers, clinically defined by purulent discharge, green discoloration or fever, or positive culture, ulcers with exposed bone with no underlying granulation tissue, HIV, HCV, HBV patients.
  • Patients who are with unrealistic expectations and unwilling to give consent for treatment or photography.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERplatelet-rich plasma

Under aseptic conditions, 20 mL of whole blood will be withdrawn from each patient and will be collected in the centrifuge tube prefilled with Anticoagulant Citrate Dextrose (1.5 mL each). A two-stage centrifugation process (double-spin method) will be employed for the preparation of PRP. The first spin is at 100 relative centrifugal force (RCF) (g) for 10 min, while the second spin is at 400 RCF for 10 min. PRP will be injected into the base of the ulcer and the surrounding skin. Group A: will receive treatment that will include PRP application, conventional debridement, and dressing coverage. Sessions will be repeated weekly for a maximum of eight sessions.

OTHERplatelet-rich fibrin

20 ml blood will be drawn from each patient by venipuncture under aseptic precautions in four sterile glass tubes of 5-ml capacity without anticoagulant and immediately centrifuged. A single stage centrifugation process, that is (200 g for 8 min), has been found to produce a fibrin clot with the highest platelet and WBC count and highest overall cumulative growth factor yield. Group B: will receive treatment that will include PRF application, conventional debridement, and dressing coverage. Sessions will be repeated weekly for a maximum of eight sessions.

OTHERSurgical debridement, normal saline washing and dressing coverage

Each patient will receive the same conventional debridement and dressing coverage (After opening the bandage, the ulcer will be irrigated with normal saline and will be prepared for debridement as required to remove dead tissues and hyperkeratotic skin. Then, a second wash with normal saline will be done to remove any debris), but without any PRP nor PRF application.


Locations(1)

Badr Hospital - Helwan University and Kafrelseikh University Hospital

Cairo, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06281483