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 fold scar. Autologous fat and steroid injections have been described to manage vocal fold scar, and have 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. It also has anti-fibrotic effects that are favourable in the treatment of vocal fold scar. Patients will be recruited to undergo nanofat injection for both vocal fold scar. 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 injection will be compared with steroid injections.
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 investigate the r
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 investigate the role of nanofat injection in vocal fold scar. Patients in this arm will either receive up to 1 mL of dexamethasone (4 mg/mL) versus up to 1 mL of nanofat as a superficial sub-epithelial vocal fold injection into the area of scar. 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 fat is harvested from the patient (patients' autologous fat). 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 general anaesthetic. The dose administered is difficult to be quantified. This is because different patients will have different degrees of vocal cord scar in addition to patient anatomical variation. In addition, it is also difficult to quantify the exact amount of grafted nanofat, because some may extrude from the injection site after removing the needle. 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
vocal cord scar
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