Clinical trial NCT04839276: Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis
Official title: The Effect of Administering Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Unilateral Adductor Vocal Cord Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vocal Cord Paralysis
Keywords: platelet-rich fibrin
vocal cord paralysis
dysphonia
injection laryngoplasty
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will receive injection laryngoplasty with a combination of PRF and microlobular autograph fat, while the control group will receive injection laryngoplasty with microlobular autograph fat.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Subject is diagnosed with unilateral vocal cord paralysis in paramedian position or 3 months lateral onset without movement and mucosal waves of the vocal cords on videostroboscopy.
* Willing to give consent

Exclusion Criteria:

* Has a history of malignancy of the larynx or lung
* Subject isn't able to undergo injection laryngoplasty procedure under general anesthesia
* Subject with thrombositopenia

Primary outcomes:
measure: Change in Voice Handicap Index-30 (VHI-30) questionnaire score
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Maximum Phonation Time
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Average Fundamental Frequency (F0)
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Jitter and Shimmer
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Noise to Harmonic Ratio (NHR)
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Voice Turbulence Index (VTI)
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Amplitude Tremor Intensity Index (ATRI)
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Vocal Cord Closure Pattern
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Amplitude
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Mucosal Waves
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Vertical Level
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Supraglottic Activity
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Non-vibrating Parts
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Free Edge Contours
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Symmetrical Pattern
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in Closure Phase
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
measure: Changes in The Stability of The Vocal Cords
timeFrame: Before injection, 1 week, 4 week, 8 week post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Department of ENT, Faculty of Medicine, University of Indonesia
name: Mirta H Reksodiputro, SpTHT-KL(K)
role: STUDY_CHAIR
affiliation: Department of ENT, Faculty of Medicine, University of Indonesia
name: Syahrial M Hutauruk, SpTHT-KL(K)
role: STUDY_CHAIR
affiliation: Department of ENT, Faculty of Medicine, University of Indonesia
name: Trimartani Koento, SpTHT-KL(K)
role: STUDY_CHAIR
affiliation: Department of ENT, Faculty of Medicine, University of Indonesia
name: Fauziah Fardizza, SpTHT-KL(K)
role: STUDY_CHAIR
affiliation: Department of ENT, Faculty of Medicine, University of Indonesia
name: Razki YM Hakim, SpTHT-KL
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of ENT, Faculty of Medicine, University of Indonesia
name: Sacha Audindra, M.D, BMedSci
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of ENT, Faculty of Medicine, University of Indonesia
name: Mikhael Yosia, M.D, DTM&H
role: PRINCIPAL_INVESTIGATOR
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citation: 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.