Effectiveness and safety of topical autologous platelet-rich fibrin membrane with total contact cast versus perilesional injectable autologous platelet-rich plasma therapy with total contact cast in trophic ulcer due to leprosy: A randomised controlled trial

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dc.contributor.authorMukherjee, Aen_US
dc.contributor.authorDas, Sen_US
dc.contributor.authorRoy, Sen_US
dc.contributor.authorPatra, ACen_US
dc.contributor.authorGhosh, Aen_US
dc.contributor.authorSil, Aen_US
dc.contributor.authorDas, NK.en_US
dc.date.accessioned2025-06-18T11:42:21Z
dc.date.available2025-06-18T11:42:21Z
dc.date.issued2025-04
dc.description.abstractIntroduction: With a vision of a 90% reduction of grade 2 disability (G2D) in the Global Leprosy Strategy by 2030, the management of trophic ulcer, a common G2D, has become a priority. Autologous injectable perilesional platelet rich plasma (PRP) is first generation, whereas autologous platelet rich fibrin membrane (PRFM) is second generation platelet concentrate helping in trophic ulcer healing by providing growth factors and cytokines. PRFM requires less amount of blood (8 mL) against 20 mL in PRP. Objectives: Evaluate the effectiveness and safety of PRFM with total contact cast versus PRP with total contact cast in leprosy trophic ulcer. Methods: Observer-blind, non-inferiority randomised controlled trial recruited clinically diagnosed leprosy trophic ulcer with wound area measurement <40 cm2 after obtaining informed consent. Calculated sample size was 26 per group considering the percentage success in the control group (PRP) 39.29% and the experimental group (PRFM) 55.55%, 5% significance- level, 80% power, non-inferiority limit 10%, and 10% drop-out rate. Randomisation was done by computer generated random number table and allocation concealment by sequentially numbered opaque sealed envelope (SNOSE) technique. PRP was prepared with first spin 1,600 rpm for 10 minutes and second spin 4,000 rpm for 10 minutes. PRFM was prepared by centrifugation at 2,600 rpm for 3 minutes. Four treatment sessions followed by two follow-ups at 2 weekly intervals were conducted. Results: Baseline clinico-demographic profile was similar in both groups. The surface area was significantly reduced (Friedman’s ANOVA P<0.001) in both PRP (from 422.48+657.30 sq cm to 247.84+635.96 sq cm) and PRFM (290.04+281.42 sq cm to 152.77+336.09 sq cm) with significant reduction from first FU onwards in both groups (Post-Hoc Dunn’s test P<0.001). Complete improvement was noted in 12% of PRP and 23% of PRFM (Fischer’s test P=0.465). Both groups showed improvement in DLQI.Limitations: Short duration of treatment and follow-up (10 weeks). Conclusion: PRFM with total contact cast is not inferior to PRP. Because of operational ease (less blood, less time), PRFM is a better alternative to PRP.en_US
dc.identifier.affiliationsDepartment of Dermatology, Bankura Sammilani Medical College, Kenduadihi, Bankura, Indiaen_US
dc.identifier.affiliationsDepartment of Dermatology, Bankura Sammilani Medical College, Kenduadihi, Bankura, Indiaen_US
dc.identifier.affiliationsDepartment of Dermatology, Deben Mahata Government Medical College, Durgapur, Indiaen_US
dc.identifier.affiliationsDepartment of Dermatology, Bankura Sammilani Medical College, Kenduadihi, Bankura, Indiaen_US
dc.identifier.affiliationsDepartment of Dermatology, Bankura Sammilani Medical College, Kenduadihi, Bankura, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmacology, Medical College, Kolkata, Indiaen_US
dc.identifier.affiliationsDepartment of Dermatology, College of Medicine and Sagore Dutta Hospital, Kamarhati, Kolkata, Indiaen_US
dc.identifier.citationMukherjee A, Das S, Roy S, Patra AC, Ghosh A, Sil A, Das NK.. Effectiveness and safety of topical autologous platelet-rich fibrin membrane with total contact cast versus perilesional injectable autologous platelet-rich plasma therapy with total contact cast in trophic ulcer due to leprosy: A randomised controlled trial. Indian Journal of Dermatology, Venereology and Leprology. 2025 Apr; 91(2): 163-171en_US
dc.identifier.issn0378-6323
dc.identifier.issn0973-3922
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/249388
dc.languageenen_US
dc.publisherScientific Scholar on behalf of Indian Association of Dermatologists, Venereologists & Leprologists (IADVL), India.en_US
dc.relation.issuenumber2en_US
dc.relation.volume91en_US
dc.source.urihttps://dx.doi.org/10.25259/IJDVL_1290_2023en_US
dc.subjectAutologous platelet-rich-fibrin-membrane,autologous platelet-rich-plasma therapyen_US
dc.subjecttotal-contact-casten_US
dc.subjecttrophic ulceren_US
dc.subjectleprosyen_US
dc.titleEffectiveness and safety of topical autologous platelet-rich fibrin membrane with total contact cast versus perilesional injectable autologous platelet-rich plasma therapy with total contact cast in trophic ulcer due to leprosy: A randomised controlled trialen_US
dc.typeJournal Articleen_US
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