RESUMEN
OBJECTIVE: To demonstrate the safety profile of platelet-rich plasma (PRP) as an injectable therapeutic for the treatment of vocal fold scarring and atrophy. METHODS: Preliminary report on a prospective clinical trial of patients with vocal fold scar or atrophy undergoing unilateral vocal fold subepithelial infusion with autologous PRP. Enrolled patients underwent four subepithelial injections spaced 1 month apart. Adverse events were assessed peri and post-injection at each session. Patient-reported outcomes were collected at every visit using the Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI) questionnaires. RESULTS: Twelve patients underwent unilateral vocal fold injection with autologous PRP prepared according to Eclipse PRP® system protocol. Forty-three injections were performed using a peroral or percutaneous approach. An average of 1.57 ± 0.4 cc (range 0.6-2.0 cc) injectate was used. All patients tolerated the procedure without difficulty or peri-procedural complications. The average duration of follow-up was 3.6 ± 1.8 months. No significant inflammatory reactions or adverse events were seen to date. There was statistically significant improvement in patient-reported outcomes at the 3 month follow up (n = 9) follow-up (mean ΔVHI-10 = 10.8, p < 0.001, mean ΔVFI = 18.9, p = 0.01, t test, paired two sample for means, two-tail). All nine patients who completed the series of four injections subjectively (yes/no) reported they were satisfied with the results. CONCLUSION: This prospective study cohort demonstrated a favorable safety profile, with no adverse events or peri-procedural complications. Subjective improvements in vocal quality and reduction in vocal fatigue need to be clinically correlated with further study. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:647-653, 2023.