Comparison of Efficacy of Autologous Platelet Rich Fibrin (PRF) Over Moist Sterile Saline Dressing in Chronic Venous Leg Ulcers: A Randomized Control Trial

Anirudh, Somani (2017) Comparison of Efficacy of Autologous Platelet Rich Fibrin (PRF) Over Moist Sterile Saline Dressing in Chronic Venous Leg Ulcers: A Randomized Control Trial. Masters thesis, PSG Institute of Medical Sciences and Research, Coimbatore.


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OBJECTIVES OF STUDY: Overall : To compare the efficacy of autologous PRF with moist saline dressing in patients with chronic venous leg ulcer. Specific : To compare the mean reduction in ulcer area at end of 4 weeks. JUSTIFICATION / RATIONALE FOR THE CONDUCT OF STUDY: Chronic venous leg ulcers is a result of the progression of chronic venous insufficiency. This often affects the quality of life of patients and shows a protracted healing, resulting in economic burden. Cutaneous wound healing involves release of platelet growth factors and chronic wounds have been hypothesized to be deficient in them. It has been suggested that topical administration of platelet derivates, including “platelet-rich plasma” and “platelet gel” can enhance tissue repair. Platelet derivates have been used to accelerate tissue repair in orthopaedic surgery, dental surgery, plastic surgery, and chronic diabetic ulcers. Justification for the study: Topical platelet derivates have been found to be efficacious in enhancing tissue repair, including cutaneous ulcers of varied etiology, in randomized control trials. Inclusion Criteria : Patients with chronic venous leg ulcers of lower extremity of > 6 months duration, attending the out-patient department, having an ulcer area of 1cm x 1cm to 5cm x 5 cm. Exclusion Criteria : (i) Ulcers < 6 months duration, (ii) Ulcers of other etiology e.g. neuropathic ulcer/arterial ulcer/diabetic ulcer/ulcer with Underlying vasculitis, (iii) Patients with osteomyelitis affecting the area of the ulcer, (iv) Ulcers with exposure of tendons or bones, (v) Ulcers with area <1cm x 1cm or > 5cm x 5cm, (vi) Ulcers with copious discharge /overt infection /infected with Pseudomonas, (vii) Hb < 11 gm/dl and/or platelet count < 1,50,000/ mm3, (viii) Patients receiving anti-coagulants/ anti-platelet drugs/ bleeding diathesis, (ix) Patients with age < 18 years or > 65 years, (x) Pregnancy and lactation, (xi) Non-consenting patients. METHODOLOGY : Study design: Open labeled prospective randomized control trial No. of groups to be studied, their names and definitions: 2 groups Group 1 (Treatment Group): Patients with chronic venous ulcer receiving Platelet Rich Fibrin (PRF) along with standardized regimen of good wound care and rest. Group 2 (Control Group): Patients with chronic venous ulcer receiving moist saline dressings along with standardized regimen of good wound care and rest. Sample size : 15. Sampling method : All patients with chronic venous c ulcer of lower extremities, and satisfying the inclusion & exclusion criteria shall be included in the study. Randomization technique : Simple randomization technique will be used to allocate the treatment to patients. It will involve computer generated random numbers which will be sealed in an envelope. Preparation of platelet-rich fibrin (PRF) : PRF preparation requires a table centrifuge under sterile precautions. 10 ml of patient’s own whole blood will be drawn into vacutainer tubes without anticoagulant and immediately centrifuged at 3000 rpm for 15 minutes. A fibrin clot is obtained in the middle of the tube, just between the RBCs at the bottom and acellular plasma at the top. 10 ml of whole blood will yield about 2.5 ml of clot. This clot will be removed from the tube under aseptic precautions with the help of sterile forceps and the attached RBCs will be scraped off and discarded. Fibrin clot will be used for dressing immediately. Dressing procedure : Group 1 will receive PRF clot dressing. It will be applied over the wound surface in a thin layer and covered with sterile saline gauze (primary dressing) followed by cotton pad and roller bandage (secondary dressing). The secondary dressing will be changed daily whereas the primary dressing will be left in place for 1 week. After 1 week, all PRF remnants will be removed with water and sterile gauze. Following this, the next PRF treatment shall be given. A total of four PRF treatments at weekly intervals shall be given for a total duration of 4 weeks. Group 2 will receive only sterile saline soaked gauze dressing which will be changed weekly. Baseline measures after randomization: i) Ulcer margins (length & breadth) in mm: by measuring greatest length and the greatest width. ii) Digital photography taken at beginning and end of treatment iii) Outcome measures at the end of four weeks CONCLUSION : In our study, there was high ulcer reduction rate at the end of 4 weeks in the patients treated with PRF dressings when compared to the saline group, which was statistically significant. As this procedure is effective, simple, patient friendly, cost effective, painless and can be done as an outpatient procedure, we would like to conclude that the use of Platelet Rich Fibrin dressings as an adjuvant therapy in the treatment of chronic venous ulcer is effective, as it shows great potential to achieve complete closure of ulcers and can successfully be used as a routine procedure in the treatment of venous ulcers.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Platelet rich fibrin ; venous ulcers ; healing.
Subjects: MEDICAL > Dermatology Venereology and Leprosy
Depositing User: Subramani R
Date Deposited: 25 Dec 2017 18:34
Last Modified: 25 Dec 2017 18:34

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