Comparison of efficacy of autologous platelet-rich fibrin versus saline dressing in chronic venous leg ulcers: A randomised controlled trial

Abstract

Background:Venous leg ulcer is a chronic condition, and various treatment modalities are available. Platelet-rich fibrin (PRF) is one of the newer modalities and it contains fibroblast growth factor (GF), vascular endothelial GF, angiopoitin and platelet-derived GF which enhances the wound healing. Hence, we conducted a randomised controlled trial to compare the efficacy of PRF versus saline dressing in chronic venous leg ulcers.Aim:This study aims to compare the efficacy of autologous PRF with saline dressing in patients with chronic venous leg ulcer and to compare the mean reduction in ulcer area at the end of 4 weeks.Materials and Methods:Fifteen patients with chronic venous leg ulcers of >6 months duration having an ulcer area of 1 cm × 1 cm to 5 cm × 5 cm were taken into the study and were randomly divided into two groups. Group 1: Patients received PRF dressing. Ten millilitres of patient's blood was taken and centrifuged at 3000 rpm for 15 min. A fibrin clot obtained in the middle of the tube was removed and used for dressing over the wound surface. It was repeated every week for 4 weeks. Group 2: Patients received saline dressings once a week for 4 weeks. The assessment of the ulcer size was done with the help of photographs, and ulcer area was measured.Results:The mean reduction in the area of the ulcer size in PRF group was 85.51%, and the mean reduction in the area of the ulcer size in Saline group was 42.74% which was statistically significant with a P < 0.001 and t = 4.11.Conclusion:We conclude that PRF dressing can be used as it is effective, inexpensive, safe and an outpatient procedure.

Treatment of venous ulcers with growth factors: systematic review and meta-analysis

“…CINAHL (((MH "Randomized Controlled Trials") OR (MH "Clinical Trials+") OR ("controlled clinical trial") OR (MH "Clinical Trial Registry") OR (MH "Random Assignment") OR (MH "Stratified Random Sample") OR (MH "Systematic Random Sample") OR "randomized") OR ("placebo") OR ("randomly") OR (MH "Multicenter Studies") OR (MH "Intervention Trials") OR ("trial")) AND ((MH "Platelet-Derived Growth Factor") OR ("platelet-derived growth factor") OR (MH "Platelet-Rich Plasma") OR (MH "Epidermal Growth Factors") OR (MH "Growth Substances+") OR (MH "Vascular Endothelial Growth Factors+") OR ("recombinant platelet-derived growth factor") OR ("fibroblast growth factor") OR ("recombinant fibroblast growth factor") OR ("recombinant endothelial growth factor") OR ("transforming growth factor") OR ("recombinant transforming growth factor") OR ("recombinant epidermal growth factor") OR (MH "Blood Platelets")) AND ((MH "Venous Ulcer") OR (MH "Leg Ulcer+") OR ("venous leg ulcer") OR ("varicose ulcer"))) LILACS ((mh: "Platelet-Rich Plasma" OR tw:growth factor$ OR tw:recomb$ growth factor OR mh:"Platelet-derived growth factor" OR mh:"epidermal growth fator" OR mh:"transforming Growth Factors" OR mh:"Fibroblast Growth Factors" OR mh:"Vascular Endothelial Growth Factor" OR tw:plasma ricoemplaqueta$ OR tw:fator$ de crescimento$ OR tw: Factor$ de Crecimiento$) AND (mh:"varicose ulcer" OR tw:venous ulcer$ OR tw:venous leg ulcer$ OR tw: úlceravenosa)) Eight hundred and two participants with venous ulcers were recruited to participate in the 10 studies included in this review. The majority of the participants received compression therapy as adjunctive therapy, having only one study (18) that did not use compression bandaging. 472 participants were treated with growth factors and 330 received standard treatment and/or placebo.…”

“…With the exception of 1 study (18) , all of them considered chronic venous ulcers with more than 6 months of evolution at admission, with a mean ulcer duration of 14.32 months (SD ± 14.11) in the group that received growth factors and 16.04 months (SD ± 19.97) in the control group. In relation to the size, the group that received growth factors had ulcers with a mean of 8,722 cm 2 (SD ± 2.93) and the control group, a mean of 8,504 cm 2 (SD ± 4.50).…”

“…The J study (26) was classified as high risk for not reporting its results completely. Studies A, B, C, D, E, F, G and H were classified as being moderate risk of bias due to failures in the description of randomization method and/ or secrecy of allocation or by failures in the description of masking applied in the research (18)(19)(20)(21)(22)(23)(24) .…”

“…In view of this, ten studies were included in this review, four of them evaluated the action of Platelet-Rich Plasma (18)(19)21,24) ; the others evaluated recombinant growth factors (20,(22)(23)(25)(26) .…”

“…From 2000, the studies that used Platelet-Rich Plasma as a primary source for the application of growth factors in venous ulcers. However, in the last decade, only 2 Randomized Clinical Trials (18)(19) were conducted. A hypothesis for the low production of RCTs could involve the little encouraging results obtained so far.…”