drugset / Trial / NCT04839276
Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis
RandomizedParallel-groupSingle-blindSupportive care
Summary
The study tries to see the effect of using a combination of platelet-rich fibrin (PRF) and autologous fat as a filler for injection laryngoplasty procedures to treat unilateral adductor vocal cord paralysis.
Timeline
- Start
- 2018-01-01
- Primary completion
- 2018-06-01
- Completion
- 2019-02-01
Publications
- Background Stachler RJ, Francis DO, Schwartz SR, Damask CC, Digoy GP, Krouse HJ, McCoy SJ, Ouellette DR, Patel RR, Reavis CCW, Smith LJ, Smith M, Strode SW, Woo P, Nnacheta LC. Clinical Practice Guideline: Hoarseness (Dysphonia) (Update) Executive Summary. Otolaryngol Head Neck Surg. 2018 Mar;158(3):409-426. doi: 10.1177/0194599817751031.
- Background Rubin AD, Sataloff RT. Vocal fold paresis and paralysis. Otolaryngol Clin North Am. 2007 Oct;40(5):1109-31, viii-ix. doi: 10.1016/j.otc.2007.05.012.
- Background Mattei A, Desuter G, Roux M, Lee BJ, Louges MA, Osipenko E, Sadoughi B, Schneider-Stickler B, Fanous A, Giovanni A. International consensus (ICON) on basic voice assessment for unilateral vocal fold paralysis. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Feb;135(1S):S11-S15. doi: 10.1016/j.anorl.2017.12.007. Epub 2018 Feb 3.
- Background Seyed Toutounchi SJ, Eydi M, Golzari SE, Ghaffari MR, Parvizian N. Vocal cord paralysis and its etiologies: a prospective study. J Cardiovasc Thorac Res. 2014;6(1):47-50. doi: 10.5681/jcvtr.2014.009. Epub 2014 Mar 4.
- Background Kwon TK, Buckmire R. Injection laryngoplasty for management of unilateral vocal fold paralysis. Curr Opin Otolaryngol Head Neck Surg. 2004 Dec;12(6):538-42. doi: 10.1097/01.moo.0000144393.40874.98.
- Background Graboyes EM, Bradley JP, Meyers BF, Nussenbaum B. Efficacy and safety of acute injection laryngoplasty for vocal cord paralysis following thoracic surgery. Laryngoscope. 2011 Nov;121(11):2406-10. doi: 10.1002/lary.22178. Epub 2011 Oct 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Platelet Concentrate | Other / unclassified | 4 ml | Other |