None listed
Conditions
Brief summary
Glottic insufficiency can have negative effects on patient quality of life. This condition mainly affects the quality and strength of voice. Glottic insufficiency can be due to vocal cord paralysis. Autologous fat injection is a well-known technique used to manage paralysis, and has been utilised for many years as a valid technique. A new method of processing fat has been described whereby harvested fat can be processed and filtered quickly and efficiently, leaving behind an easily injectable liquid with a high number of stem cells, without requiring long processing times and highly specialised equipment. It is potentially a modern refinement and improvement of a long-standing technique. The proposed benefit of nanofat supplementation is that the volume of the injected cord is maintained for longer compared to fat grafting alone. due to increased adipocyte survival. Patients will be recruited to undergo nanofat injection for vocal fold paralysis. Prior to the surgery, patients will fill out questionnaires and have their vocal cords examined via stroboscopy and undergo objective acoustic and aerodynamic assessment. They will then undergo treatment with follow up assessments occurring at multiple timepoints thereafter, as described in our protocol. The effect of nanofat treatment will be compared with standard of care treatment.
Interventions
Nanofat involves mechanically emulsifying and filtering harvested fat. The technique does not require the use of a surgical laboratory, proteolytic enzyme reagents, or specialised equipment. Studies have shown nanofat to contain stromal vascular fraction (SVF) - a non-adipocyte, supportive component of harvested fat and contains a complex population of fibroblasts, macrophages, immune regulatory cells, and a high density of adipocyte-derived stem cells (ADSC).
This study will look at vocal fol
Nanofat involves mechanically emulsifying and filtering harvested fat. The technique does not require the use of a surgical laboratory, proteolytic enzyme reagents, or specialised equipment. Studies have shown nanofat to contain stromal vascular fraction (SVF) - a non-adipocyte, supportive component of harvested fat and contains a complex population of fibroblasts, macrophages, immune regulatory cells, and a high density of adipocyte-derived stem cells (ADSC). This study will look at vocal fold paralysis. Patients will be randomised to either autologous fat injection (fat harvested from the patient and injected to the paralysed cord) only or autologous fat plus autologous nanofat injection. The senior researcher (PP, ENT surgeon) will perform all injections. All injections would take place at a tertiary hospital setting in an operating theatre under general anaesthetic. Fat is processed on-site to isolate cells. The sieving process will be the same as the technique already described in the literature by Tonnard et al. The harvested fat will be mechanically emulsified by shifting the sample between two 10-mL syringes connected to each other by Luer-Lok connection. The fat then becomes an emulsion after 30 passes. Following the emulsification process, the liquid is filtered for injection. The harvesting process should take no longer than 30 minutes. All injections occur under general anaesthetic and direct microlaryngoscopy. The entire procedure should be completed in one hour. The harvest and intervention administration occurs under the same anaesthetic. The dose administered is difficult to be quantified. This is because different patients will have different degrees of vocal cord lateralisation in addition to other anatomic factors (bulk required to medialise vocal cord, size, length, etc). In addition, it is also difficult to quantify the amount of grafted fat exactly, because some may extrude from the injection site after removing the needle. In general, a total of 0.5 to 2 mL of nanofat will be injected. The amount injected at the time of the procedure will be recorded by the operator.
Sponsors
Department of Otolaryngology, Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
unilateral vocal cord paralysis
Exclusion criteria
evidence of other vocal fold abnormalities (granuloma, polyps, sulcus or other pathology affecting vocal fold vibration), previous history of glottic cancer, previous laser resection of the vocal fold, prior radiotherapy
Outcome results
None listed