Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial
PurposeTo 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.Materials and MethodsPatients were randomly allocated to treat...
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Frontiers Media S.A.
2021-07-01
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| Series: | Frontiers in Bioengineering and Biotechnology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fbioe.2021.677541/full |
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| author | Domen Vozel Domen Vozel Darja Božič Darja Božič Marko Jeran Marko Jeran Zala Jan Manca Pajnič Ljubiša Pađen Nejc Steiner Veronika Kralj-Iglič Veronika Kralj-Iglič Saba Battelino Saba Battelino |
| author_facet | Domen Vozel Domen Vozel Darja Božič Darja Božič Marko Jeran Marko Jeran Zala Jan Manca Pajnič Ljubiša Pađen Nejc Steiner Veronika Kralj-Iglič Veronika Kralj-Iglič Saba Battelino Saba Battelino |
| author_sort | Domen Vozel |
| collection | DOAJ |
| description | PurposeTo 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.Materials and MethodsPatients 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.ResultsEleven 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 (p < 0.001) but not in the control group (p = 0.339). The CPTBCI foci surface area decreased statistically significantly between the first and second checkups (p < 0.0005) but not between other checkups (p > 0.05) in the PVRP group. No statistically significant differences in CPTBCI foci surface area were detected between checkups in the control group (p = 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.ConclusionAutologous 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.Trial Numberhttps://clinicaltrials.gov (NCT04281901). |
| first_indexed | 2024-12-14T20:20:07Z |
| format | Article |
| id | doaj.art-092f98e80bdd4112a566339a8de7888f |
| institution | Directory Open Access Journal |
| issn | 2296-4185 |
| language | English |
| last_indexed | 2024-12-14T20:20:07Z |
| publishDate | 2021-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Bioengineering and Biotechnology |
| spelling | doaj.art-092f98e80bdd4112a566339a8de7888f2022-12-21T22:48:45ZengFrontiers Media S.A.Frontiers in Bioengineering and Biotechnology2296-41852021-07-01910.3389/fbioe.2021.677541677541Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical TrialDomen Vozel0Domen Vozel1Darja Božič2Darja Božič3Marko Jeran4Marko Jeran5Zala Jan6Manca Pajnič7Ljubiša Pađen8Nejc Steiner9Veronika Kralj-Iglič10Veronika Kralj-Iglič11Saba Battelino12Saba Battelino13Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, Ljubljana, SloveniaFaculty of Medicine, University of Ljubljana, Ljubljana, SloveniaLaboratory of Clinical Biophysics, Faculty of Health Sciences, University of Ljubljana, Ljubljana, SloveniaLaboratory of Physics, Faculty of Electrical Engineering, University of Ljubljana, Ljubljana, SloveniaLaboratory of Clinical Biophysics, Faculty of Health Sciences, University of Ljubljana, Ljubljana, SloveniaLaboratory of Physics, Faculty of Electrical Engineering, University of Ljubljana, Ljubljana, SloveniaLaboratory of Clinical Biophysics, Faculty of Health Sciences, University of Ljubljana, Ljubljana, SloveniaLaboratory of Clinical Biophysics, Faculty of Health Sciences, University of Ljubljana, Ljubljana, SloveniaLaboratory of Clinical Biophysics, Faculty of Health Sciences, University of Ljubljana, Ljubljana, SloveniaDepartment of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, Ljubljana, SloveniaLaboratory of Clinical Biophysics, Faculty of Health Sciences, University of Ljubljana, Ljubljana, SloveniaExtracellular Vesicles and Mass Spectrometry Laboratory, Institute of Biosciences and BioResources, National Research Council of Italy, Naples, ItalyDepartment of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, Ljubljana, SloveniaFaculty of Medicine, University of Ljubljana, Ljubljana, SloveniaPurposeTo 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.Materials and MethodsPatients 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.ResultsEleven 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 (p < 0.001) but not in the control group (p = 0.339). The CPTBCI foci surface area decreased statistically significantly between the first and second checkups (p < 0.0005) but not between other checkups (p > 0.05) in the PVRP group. No statistically significant differences in CPTBCI foci surface area were detected between checkups in the control group (p = 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.ConclusionAutologous 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.Trial Numberhttps://clinicaltrials.gov (NCT04281901).https://www.frontiersin.org/articles/10.3389/fbioe.2021.677541/fullregenerative medicinemastoidectomycholesteatomatheranostic nanomedicinequality of lifetemporal bone |
| spellingShingle | Domen Vozel Domen Vozel Darja Božič Darja Božič Marko Jeran Marko Jeran Zala Jan Manca Pajnič Ljubiša Pađen Nejc Steiner Veronika Kralj-Iglič Veronika Kralj-Iglič Saba Battelino Saba Battelino Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial Frontiers in Bioengineering and Biotechnology regenerative medicine mastoidectomy cholesteatoma theranostic nanomedicine quality of life temporal bone |
| title | Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial |
| title_full | Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial |
| title_fullStr | Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial |
| title_full_unstemmed | Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial |
| title_short | Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial |
| title_sort | autologous platelet and extracellular vesicle rich plasma is an effective treatment modality for chronic postoperative temporal bone cavity inflammation randomized controlled clinical trial |
| topic | regenerative medicine mastoidectomy cholesteatoma theranostic nanomedicine quality of life temporal bone |
| url | https://www.frontiersin.org/articles/10.3389/fbioe.2021.677541/full |
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