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

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Vocal Cord Paralysis

Treatments: Combination Product: Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat; Procedure: Injection Laryngoplasty with Autologous Fat

Study type: Interventional

Funder types: Other

Identifiers

NCT04839276

THT02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Injection Laryngoplasty with PRF and Autologous Fat

Experimental group

Description:

Autologous microlobular fat is harvested from abdominal fat (area under the umbilical). 4 mL of microlobular fat is added to 4 mL of PRF and is smoothed by pushing it back and forth 15 times on a 2-tube 10 mL piston tube connected to a three-way connector. 3 mL of the mixture of fat and PRF is injected using a 12 G laryngoplasty syringe until medialization is achieved.

Treatment:

Combination Product: Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat

Injection Laryngoplasty with Autologous Fat

Active Comparator group

Description:

Autologous microlobular fat is harvested from abdominal fat (area under the umbilical). 4 mL of microlobular fat is mashed by pushing it back and forth 15 times in a container of 2 piston tubes (10 mL) connected to a three-way connector. The crushed fat is injected as much as 3 mL using a 12 G laryngoplasty syringe until medialization is achieved.

Treatment:

Procedure: Injection Laryngoplasty with Autologous Fat