Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis
Condition: Vocal Cord Paralysis
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat; Injection Laryngoplasty with Autologous Fat
Intervention type(s): Combination Product; Procedure
Intervention description(s): 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.; 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 intervention name(s): RegenKit PRP Tube (Regen Lab); Lipid Autograft
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention group will receive injection laryngoplasty with a combination of PRF and microlobular autograph fat, while the control group will receive injection laryngoplasty with microlobular autograph fat.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: platelet-rich fibrin; vocal cord paralysis; dysphonia; injection laryngoplasty