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Completed

NCT Number: NCT04839276

Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis

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.

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Key information

Conditions

Vocal Cord Paralysis Cranial Nerve Diseases Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Voice Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10450, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat

Combination Product

Injection Laryngoplasty with a combination of Platelet-rich Fibrin (PRF) and Autologous Fat. The PRF was made by taking 10 mL of peripheral blood from a healthy donor. Blood is then put inside the tube from the Regen lab kit. The tube was centrifuged with a force of 1,500 g (3000 rpm) for 5 minutes producing platelet-rich plasma (PRP). 4 mL of the aforementioned PRP was transferred to a 10 mL test tube, 1 M CaCl2 was added with a micropipette until final concentration of 25 mM was, reached producing PRF. Autologous fat harvested from the patient's abdomen was then mixed with the PRF solution to create the filler for injection laryngoplasty procedures. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords.

Other names: RegenKit PRP Tube (Regen Lab)

Injection Laryngoplasty with Autologous Fat

Procedure

Injection Laryngoplasty with autologous microlobular fat harvested from the patient's abdominal fat. Lidocaine was infiltrated under the umbilicus and then an incision was made in the area followed by fat removal using scissors. The fat was cleaned with 0.9% NaCl solution and then sheared into microlobular form. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords.

Other names: Lipid Autograft

Primary outcomes

  1. Change in Voice Handicap Index-30 (VHI-30) questionnaire score

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The Voice Handicap Index Questionnaire-30 (VHI-30) is a subjective examination that can be used to assess the severity of voice disorders and their impact on social life. The VHI-30 categorizes handicaps into mild, moderate, and severe. This study assessed the VHI-30 score as a numerical scale so that the median value for the treatment and control groups can be obtained. The assessment was carried out based on the patient's perception by addressing complaints for each question (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). Patients with severe voice disorders will achieve a higher VHI-30 score. Interpretation of the total value of the VHI-30 includes mild disability values of 0 - 30; moderate disability of 31 - 60; and a severe disability of 61-120. Changes in VHI-30 score are recorded and statistically analysed.

  2. Changes in Maximum Phonation Time

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    Maximum phonation time describes the quality of the strength of the vocal cords when oscillating. The calculation of the phonation time will represent objective assessment of voice. Changes in maximum phonation time are recorded and statistically analysed.

  3. Changes in Average Fundamental Frequency (F0)

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The Average Fundamental Frequency (F0) is a parameter in MDVP that represents the number of vocal cord vibration cycles in one second. The mean frequency ranges from 120 Hz for men and 200 Hz for women, but this is also influenced by age, smoking and accent language. The average fundamental frequency reflects the biochemical characteristics of the vocal cords when interacting with the air flow in its path, these biochemical properties are influenced by the structure of the larynx and muscle tone. Changes in F0 are recorded and statistically analysed.

  4. Changes in Jitter and Shimmer

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    Jitter and Shimmer is a parameter in MDVP that represents variations that occur in the basic frequency. Jitter denotes the chaos of sound wave frequency caused by a lack of control over the vibration of the vocal cords. Shimmer shows the chaos of sound wave amplitude which is influenced by decreased resistance of the glottis and presence of mass lesions of the vocal cords, associated with inadequate adduction of the vocal cords and irregularity of the surface of the vocal cords. Presence of jitter and shimmer denotes that there are disruption in phonation quality caused by problems in vocal cords. Changes in jitter and shimmer are recorded and statistically analysed.

  5. Changes in Noise to Harmonic Ratio (NHR)

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    NHR is a parameter in MDVP that represents ratio of non-harmonic and harmonic waves in a certain sound wave period. NHR describes the quality of the amount of noise in the sound. Inadequate closure of the vocal cords and periodic vibrations of the vocal cords cause excessive air flow as it passes through the vocal cords, causing turbulence and noise. Normal and periodic sound signals will have a small NHR, while dysphonia sound signals will have a large NHR value. Changes in NHR are recorded and statistically analysed.

  6. Changes in Voice Turbulence Index (VTI)

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    VTI (Voice Turbulence Index) is a parameter in MDVP that represents the ratio between non-harmonic waves at high frequencies of 2800 - 5800 Hz and harmonic waves at frequencies of 70 - 4500 Hz. This parameter assesses the energy level of high frequency noise and is largely related to the turbulence of sound caused due to loss of adduction motion. This parameter also relates to variations in the frequency or amplitude of sound, where the turbulence of sound occurs due to changes in muscle control. Changes in VTI are recorded and statistically analysed.

  7. Changes in Amplitude Tremor Intensity Index (ATRI)

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    ATRI is a parameter in MDVP that represents the mean ratio of the low frequency amplitude to the total amplitude of the sound being examined. This parameter indicates the stability and strength of the vocal cords during phonation. Changes in ATRI are recorded and statistically analysed.

  8. Changes in Vocal Cord Closure Pattern

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The closure pattern of the vocal cords is one of the parameters in videostroboscopy. This examination looks at the pattern and medial edge of the vocal cords when closed and insulated. Changes in Vocal Cord Closure Pattern are recorded and statistically analysed.

  9. Changes in Amplitude

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The amplitude is one of the parameters in videostroboscopy. Amplitude is the amount of horizontal movement of the vocal cords. The magnitude of the amplitude is assessed by dividing the horizontal line into 5 sections from medial to lateral of the vocal cords. Changes in amplitude are recorded and statistically analysed.

  10. Changes in Mucosal Waves

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The mucosal waves is one of the parameters in videostroboscopy. Mucosal waves are the movement of the vocal cords from an inferior to a superior direction following the glottic cycle on the vertical axis. Changes in mucosal waves are recorded and statistically analysed.

  11. Changes in Vertical Level

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The vertical level is a parameter of the vocal cords on videostroboscopy that describes the difference in the height of the vocal cords that meet and are seen in the medial of the vocal cords. Changes in vertical level are recorded and statistically analysed.

  12. Changes in Supraglottic Activity

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The supraglottic activity is one of the parameters in videostroboscopy. Supraglottic activity describes a narrowing of the supraglottic structure wherein one of them is a collapsed arytenoid. Changes in supraglottic activity are recorded and statistically analysed.

  13. Changes in Non-vibrating Parts

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The non-vibrating parts is one of the parameters in videostroboscopy. The non-vibrating part is the part of the vocal cords that does not experience vibrations due to tissue rigidity. Assessment of this parameter is by dividing the right and left vocal cords into 10 regions each with an oval line. Changes in non-vibrating parts are recorded and statistically analysed.

  14. Changes in Free Edge Contours

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The free edge contours is one of the parameters in videostroboscopy. This parameter represents the free edge of the medial side of the vocal cords at maximal abduction. Changes in free edge contours are recorded and statistically analysed.

  15. Changes in Symmetrical Pattern

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    This parameter assesses the symmetrical movement of the right and left vocal cords during oscillation using videostroboscopy. The results of the assessment on this parameter are symmetrical or asymmetrical. Changes in symmetrical pattern are recorded and statistically analysed.

  16. Changes in Closure Phase

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The closure phase is a parameter that compares the amount of closure and opening of the vocal cords in one glottic cycle. Assessment is done by looking at a collection of pictures from videostroboscopy when the vocal cords oscillate. Changes in closure phase are recorded and statistically analysed.

  17. Changes in The Stability of The Vocal Cords

    Time frame: Before injection, 1 week, 4 week, 8 week post-injection

    The stability of the vocal cords is a parameter that measures the vibration and amplitude of the vocal cords that are oscillating in one glottic cycle Assessment of this parameter where done through videostroboscopy. Changes in the stability of the vocal cords are recorded and statistically analysed.

Sponsors and collaborators

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Other

Registry information

Official study title

The Effect of Administering Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Unilateral Adductor Vocal Cord Paralysis

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 9, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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