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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis

NCT03749863

Presbylarynx Atrophy; Larynx Dysphonia +4 more

COMPLETED NA

Effect of PRP Injection on Voice Recovery After Benign Vocal Fold Surgery

NCT07300800

Benign Vocal Fold Lesions

NOT_YET_RECRUITING NA

Early Intracordal Hyaluronic Acid Injection During Spontaneous Reinnervation for Unilateral Recurrent Laryngeal Nerve Paralysis

NCT02163772

Paralysis, Unilateral, Vocal Cord

COMPLETED NA

Silk Protein Microparticle-based Filler for Injection Augmentation

NCT03790956

Vocal Cord Paralysis Unilateral Dysphonia Dysphagia, Oropharyngeal

COMPLETED NA

Surgery for Vocal Cord Paralysis

NCT00064571

Unilateral Vocal Cord Paralysis

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vocal Cord Paralysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

The participants of the study know that they are being assigned to injection laryngoplasty procedures, but they didn't know whether PRF is being added to the autologous fat injection filler. The researchers are fully aware which participants are assigned to which procedures.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Injection Laryngoplasty with PRF and Autologous Fat

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.

Group Type EXPERIMENTAL

Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat

Intervention Type COMBINATION_PRODUCT

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 Fat

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.

Group Type ACTIVE_COMPARATOR

Injection Laryngoplasty with Autologous Fat

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RegenKit PRP Tube (Regen Lab) Lipid Autograft

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR