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

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.

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.

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia

  lead OTHER

Principal Investigators

• Mirta H Reksodiputro, SpTHT-KL(K) · Department of ENT, Faculty of Medicine, University of Indonesia

• Syahrial M Hutauruk, SpTHT-KL(K) · Department of ENT, Faculty of Medicine, University of Indonesia

• Trimartani Koento, SpTHT-KL(K) · Department of ENT, Faculty of Medicine, University of Indonesia

• Fauziah Fardizza, SpTHT-KL(K) · Department of ENT, Faculty of Medicine, University of Indonesia

• Razki YM Hakim, SpTHT-KL · Department of ENT, Faculty of Medicine, University of Indonesia

• Sacha Audindra, M.D, BMedSci · Department of ENT, Faculty of Medicine, University of Indonesia

• Mikhael Yosia, M.D, DTM&H · Department of ENT, Faculty of Medicine, University of Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2018-06-01

Completion

2019-02-01

Countries

• Indonesia

Study Locations