None listed
Conditions
Brief summary
This study seeks to determine the safety of applying the potent corticosteroid dexamethasone in a slow release hyaluronic acid gel formulation directly to exposed nerve branches of the facial nerve during standard parotidectomy and neck dissection surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are undergoing parotidectomy (malignant or benign) or neck dissection surgery. Study details Consenting patients will receive the dexamethasone in a slow release gel formulation directly to the exposed nerve during surgery, in which the surgeon will coat exposed branches of the facial nerve with the formulation once. Consenting participants will undergo their standard clinical treatment involving parotidectomy or neck dissection surgery which includes an initial consult involving facial nerve function assessments, parotidectomy or neck dissection surgery and follow-up visits assessing wound healing/infection and facial nerve function over 2 months.
Interventions
Phase I safety study of a topical formulation of 2.2mL of 1mg/mLdexamethasone:3%hyaluronic acid applied directly to facial nerve branches in surgery. Consenting participants will undergo their standard clinical treatment involving parotidectomy or neck dissection surgery which includes an initial consult involving facial nerve function assessments, parotidectomy or neck dissection surgery and follow-up visits assessing wound healing/infection and facial nerve function over 2 months. However, con
Phase I safety study of a topical formulation of 2.2mL of 1mg/mLdexamethasone:3%hyaluronic acid applied directly to facial nerve branches in surgery. Consenting participants will undergo their standard clinical treatment involving parotidectomy or neck dissection surgery which includes an initial consult involving facial nerve function assessments, parotidectomy or neck dissection surgery and follow-up visits assessing wound healing/infection and facial nerve function over 2 months. However, consenting patients will receive the formulation during surgery, in which the surgeon will coat exposed branches of the facial nerve with the formulation once.
Sponsors
IntraVital Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Undergoing parotidectomy (malignant or benign) or neck dissection surgery • Greater than or equal to 18 years of age.
Exclusion criteria
• Preoperative assessment that the nerve at risk will need to be intentionally sacrificed • Functional assessment by the surgeon indicating that the nerve is not functioning prior to surgery e.g. complete facial palsy • Administration of another investigational drug within 30 days prior • Significant neurological or psychiatric disorder • Pregnancy • Patients who lack capacity or whom are unable to express informed consent • Patients with a mental illness such as to interfere with their ability to understand the requirements of the study or express informed consent • Current infective illness
Outcome results
None listed