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

PHASE4CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

January 1, 2018

Primary Completion Date

June 1, 2018

Study Completion Date

February 1, 2019

Conditions
Vocal Cord Paralysis
Interventions
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.

Trial Locations (1)

10450

Fakultas Kedokteran Universitas Indonesia, Jakarta Pusat

All Listed Sponsors
lead

Fakultas Kedokteran Universitas Indonesia

OTHER

NCT04839276 - Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis | Biotech Hunter | Biotech Hunter