NCT04839276

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Fakultas Kedokteran Universitas Indonesia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vocal Cord Paralysis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat	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.
PROCEDURE	Injection Laryngoplasty with Autologous Fat	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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-06-01
• Completion: 2019-02-01
• First posted: 2021-04-09
• Last updated: 2021-04-20

Locations

1 site across 1 country: Indonesia