RecruitingPhase 2ACTRN12618000077268

Phase I non-randomised safety study of prophylactic topical dexamethasone/hyaluronic acid formulation on facial nerves during parotidectomy and neck dissection surgery


Sponsor

IntraVital Pty Ltd

Enrollment

30 participants

Start Date

Jan 31, 2018

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether applying a slow-release dexamethasone (steroid) gel directly onto exposed facial nerve branches during parotid gland or neck dissection surgery can reduce temporary facial weakness after the operation. Researchers want to confirm the treatment is safe before testing its effectiveness in larger studies. You may be eligible if: - You are aged 18 or older - You are scheduled to have parotidectomy (removal of the parotid gland) or neck dissection surgery You may NOT be eligible if: - Your facial nerve will need to be deliberately cut during surgery - Your facial nerve is already not working before surgery (e.g. you have complete facial palsy) - You are pregnant - You have an active infection or significant neurological or psychiatric disorder - You have taken another investigational drug within the past 30 days - You are unable to give informed consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 standar

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)

The Chris O’Brien Lifehouse - Camperdown

NSW, Australia

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ACTRN12618000077268


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