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Clinical Trial 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.


Clinical Trial Description

The vocal cord in humans is essential in producing voice used in communication and interaction between us. Vocal cord paralysis causes dysphonia, which interferes with communication, causing disruptions towards social activity and daily activities. One of the managements for vocal cord paralysis is medialisation and augmentation of the vocal cord through injection laryngoplasty. Autologous fat is one of the best fillers that can be used in this procedure, but it is highly absorbable and can be reabsorbed very quickly when injected to body tissues. Platelet Rich Fibrin (PRF) is a biomaterial consisting of growth factors that are thought to improve fat tissue longevity through increase of adipogenesis and angiogenesis. Improvement in fat longevity will improve clinical outcomes after laryngoplasty procedure potentially reducing number of repeated injections needed to achieve satisfactory resolution to vocal cord paralysis. The study evaluates a combination of PRF and autologous microlobular fat compared with autologous microlobular fat alone on laryngoplasty. Subjective evaluation was done by using Voice Handicap Index (VHI-30) questionnaire, while objective evaluation was conducted via computerized acoustic analysis/Multidimensional Voice Program (MDVP), videostroboscopy, and maximum phonation time. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04839276
Study type Interventional
Source Fakultas Kedokteran Universitas Indonesia
Contact
Status Completed
Phase Phase 4
Start date January 1, 2018
Completion date February 1, 2019

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