The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000077268
Ethics application status
Approved
Date submitted
10/11/2017
Date registered
18/01/2018
Date last updated
16/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I non-randomised safety study of prophylactic topical dexamethasone/hyaluronic acid formulation on facial nerves during parotidectomy and neck dissection surgery
Scientific title
Phase I non-randomised safety study of prophylactic topical dexamethasone/hyaluronic acid formulation on facial nerves during parotidectomy and neck dissection surgery
Secondary ID [1] 292653 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parotid cancer 304385 0
Neck cancer 304386 0
Parotidectomy 305820 0
Neck dissection surgery 305821 0
Condition category
Condition code
Cancer 303720 303720 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 304832 304832 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299587 0
Treatment: Drugs
Intervention code [2] 299588 0
Prevention
Comparator / control treatment
Audit of consented patients from the clinic concurrently undergoing parotidectomy or neck dissection surgery. The difference between treatment and comparator group is the administration of the formulation.
Control group
Active

Outcomes
Primary outcome [1] 303916 0
Rate of infection both systemic and at the operation site using the Australian Infection Control Association (AICA) criteria to assess superficial site and deep site infection (SSI and DSI) in addition to SIRS criteria for systemic infection which will be compiled by clinic staff members who will not be aware as to which patients have received the formulation.
Timepoint [1] 303916 0
1 day, 2 days, 2 weeks and 2 months post operation
Secondary outcome [1] 340455 0
Clinical Facial Nerve function as assessed as a composite of the:
- House Brackmann
- eFACE
- Sunnybrook Facial Grading System
These involve performing specific facial movements
Timepoint [1] 340455 0
Before, 1 day, 2 days, 2 weeks and 2 months post operation

Eligibility
Key inclusion criteria
• Undergoing parotidectomy (malignant or benign) or neck dissection surgery
• Greater than or equal to 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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


Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
One group will receive the formulation whilst a comparator group will be historically audited controls who underwent the same assessments as the treatment group.
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data will be described using standard statistical methods (mean and standard deviation, median and interquartile range or frequency and percentage, depending on the variable type) to characterize the patient population and their neurophysiological, clinical and patient-reported outcomes. Data from the participants will be compared to 20, age and sex matched audited disease/procedure controls from the center occurring concurrently with the trial and a significantly elevated rate of infection will be determined at a rate greater than 15% of the 10 patients recruited for the present study. This cutoff is informed by an internal audit of the surgical clinic to undertake the present investigation, which indicated a complication rate of 10-15% of patients whom underwent parotidectomy or neck dissection.
Analysis of functional outcome measures will provide powering data for a Phase II efficacy study in the same setting investigating the proposed formulation as a prophylactic, neuroprotective agent.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9379 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 18070 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 297287 0
Commercial sector/Industry
Name [1] 297287 0
IntraVital Pty Ltd
Address [1] 297287 0
1/54 Coogee Bay Rd
Randwick
NSW 2031
Country [1] 297287 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
IntraVital Pty Ltd
Address
1/54 Coogee Bay Rd
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 297145 0
None
Name [1] 297145 0
Address [1] 297145 0
Country [1] 297145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298397 0
SLHD RPAH
Ethics committee address [1] 298397 0
Clinical Trials Executive Officer
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 298397 0
Australia
Date submitted for ethics approval [1] 298397 0
26/08/2017
Approval date [1] 298397 0
30/10/2017
Ethics approval number [1] 298397 0
X17-0307 & HREC/17/RPAH/461

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76950 0
Prof Jonathan Clark
Address 76950 0
Chris O'Brien Lifehouse
119-143 Missenden Road
CAMPERDOWN
NSW 2050
Country 76950 0
Australia
Phone 76950 0
+61 02 8514 0131
Fax 76950 0
+61 02 9383 1131
Email 76950 0
jonathan.clark@lh.org.au
Contact person for public queries
Name 76951 0
Dr Aparna Krishnan
Address 76951 0
Chris O'Brien Lifehouse
119-143 Missenden Road
CAMPERDOWN
NSW 2050
Country 76951 0
Australia
Phone 76951 0
+61 02 8514 0131
Fax 76951 0
Email 76951 0
aparna.krishnan@lh.org.au
Contact person for scientific queries
Name 76952 0
Dr Natalie Kwai
Address 76952 0
Department of Exercise Physiology
Rm 202 Wallace Wurth Building
School of Medical Sciences
UNSW Sydney
KENSINGTON
NSW 2052
Country 76952 0
Australia
Phone 76952 0
+61 02 9385 3375
Fax 76952 0
Email 76952 0
natalie.kwai@unsw.edu.au

No data has been provided for results reporting
Summary results
Not applicable