Phase I non-randomised safety study of prophylactic topical dexamethasone/hyaluronic acid formulation on facial nerves during parotidectomy and neck dissection surgery
IntraVital Pty Ltd
30 participants
Jan 31, 2018
Interventional
Conditions
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.
Eligibility
Inclusion Criteria2
- Undergoing parotidectomy (malignant or benign) or neck dissection surgery
- Greater than or equal to 18 years of age.
Exclusion Criteria8
- 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
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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, consenting patients will receive the formulation during surgery, in which the surgeon will coat exposed branches of the facial nerve with the formulation once.
Locations(1)
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ACTRN12618000077268