AUTHOR=Vozel Domen , Božič Darja , Jeran Marko , Jan Zala , Pajnič Manca , Pađen Ljubiša , Steiner Nejc , Kralj-Iglič Veronika , Battelino Saba 

TITLE=Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial

JOURNAL=Frontiers in Bioengineering and Biotechnology

VOLUME=9

YEAR=2021

URL=https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2021.677541

DOI=10.3389/fbioe.2021.677541

ISSN=2296-4185

ABSTRACT=<sec><title>Purpose</title><p>To determine the efficacy of autologous platelet- and extracellular vesicle-rich plasma (PVRP) to treat chronic postoperative temporal bone cavity inflammation (CPTBCI) after exhausting surgical and standard conservative therapies.</p></sec><sec><title>Materials and Methods</title><p>Patients were randomly allocated to treatment with PVRP (PVRP group) or standard conservative methods (control group) in a setting of four once-monthly checkups and subsequent follow-up. The treatment outcome was measured with the Chronic Otitis Media Questionnaire-12 (COMQ-12), CPTBCI focus surface area, and CPTBCI symptom-free time after the fourth checkup.</p></sec><sec><title>Results</title><p>Eleven patients from each group completed the trial; 95% of patients suffered from chronically discharging mastoid cavity (the type of CPTBCI). Within four checkups, the COMQ-12 score decreased statistically significantly in the PVRP group (<italic>p</italic> &lt; 0.001) but not in the control group (<italic>p</italic> = 0.339). The CPTBCI foci surface area decreased statistically significantly between the first and second checkups (<italic>p</italic> &lt; 0.0005) but not between other checkups (<italic>p</italic> &gt; 0.05) in the PVRP group. No statistically significant differences in CPTBCI foci surface area were detected between checkups in the control group (<italic>p</italic> = 0.152). Nine patients from the PVRP group and three patients from the control group were CPTBCI symptom-free at the fourth checkup. The median symptom-free time was 9.2 months (95% CI [7.4, 11.9]) in the PVRP group. Cumulatively, 49% of patients in the PVRP group remained CPTBCI symptom-free for 12.7 months after the fourth checkup.</p></sec><sec><title>Conclusion</title><p>Autologous PVRP represents a novel additional and successful treatment modality for a chronically discharging radical mastoid cavity when the surgical and standard conservative treatment methods have been exhausted.</p></sec><sec><title>Trial Number</title><p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov</ext-link> (NCT04281901).</p></sec>