Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000101381
Ethics application status
Approved
Date submitted
15/01/2017
Date registered
18/01/2017
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Surgicel in Parotid Surgery
Scientific title
Does the use of Surgicel after parotidectomy in adults increases the incidence of post-operative sialocele formation
Secondary ID [1] 290921 0
Nil known
Universal Trial Number (UTN)
U1111-1191-7117
Trial acronym
USiPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sialocele 301642 0
Condition category
Condition code
Surgery 301350 301350 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgicel is used after parotidectomy in the wound bed to aid in haemostasis and to protect the facial nerve. Surgicel Original Haemostat (Ethicon) 0.5x2inch will be placed in the wound bed after parotidectomy by the treating surgeon prior to closing.
Intervention code [1] 296863 0
Treatment: Surgery
Intervention code [2] 296882 0
Treatment: Devices
Comparator / control treatment
No material/device will be placed in the wound bed at the time of surgery.
Control group
Active

Outcomes
Primary outcome [1] 300749 0
Sialocele formation which will be clinically diagnosed at the one week follow up outpatient appointment and confirmed and quantified on ultrasound
Timepoint [1] 300749 0
One week post surgery.
Secondary outcome [1] 330780 0
Drain output will be measured every 24hrs by direct observation of the drain bag by surgical staff caring for the patient and documented in the medical records.
Timepoint [1] 330780 0
Every 24 hours until drain removed
Secondary outcome [2] 330806 0
Length of hospital stay as determined by days in hospital since operation to discharge
Timepoint [2] 330806 0
Days in hospital from operation date to discharge date
Secondary outcome [3] 330807 0
Facial nerve palsy graded on the House-Brackmann scale from 1 to 5
Timepoint [3] 330807 0
Measured 2hrs, 24hrs and one week after operation

Eligibility
Key inclusion criteria
All patients undergoing a parotidectomy
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other procedures during the parotidectomy (neck dissection) and radical parotidectomies.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 295340 0
Hospital
Name [1] 295340 0
Gold Coast University Hospital
Country [1] 295340 0
Australia
Funding source category [2] 295347 0
Hospital
Name [2] 295347 0
Ipswich Hospital
Country [2] 295347 0
Australia
Funding source category [3] 295348 0
Hospital
Name [3] 295348 0
Toowoomba Hospital
Country [3] 295348 0
Australia
Funding source category [4] 295349 0
Hospital
Name [4] 295349 0
Royal Brisbane Women's Hospital
Country [4] 295349 0
Australia
Funding source category [5] 295350 0
Hospital
Name [5] 295350 0
Townsville Hospital
Country [5] 295350 0
Australia
Funding source category [6] 295351 0
Hospital
Name [6] 295351 0
Sunshine Coast University Hospital
Country [6] 295351 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard, off Parklands Drive, Southport, Gold Coast, Queensland, Australia. 4215
Country
Australia
Secondary sponsor category [1] 294174 0
None
Name [1] 294174 0
Address [1] 294174 0
Country [1] 294174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296676 0
Gold Coast University Hospital Ethics Committee
Ethics committee address [1] 296676 0
Research Directorate
Level 2, Pathology and Education Building
1 Hospital Boulevard
Southport, QLD, 4215
Ethics committee country [1] 296676 0
Australia
Date submitted for ethics approval [1] 296676 0
10/10/2016
Approval date [1] 296676 0
13/10/2016
Ethics approval number [1] 296676 0
HREC/16/QGC/272

Summary
Brief summary
The aim of this study is to evaluate the effect of Surgicel use in parotid surgery on the incidence of post-operative sialocele formation.

Who is it for?
You may be eligible to join this study if you are aged 18-90 years and are scheduled to undergo a parotidectomy.

Study details
Patients will be randomized (allocated by chance) to use of Surgicel (a type of oxidised regenerated cellulose) or no use of Surgicel in the control arm. Surgicel is used after parotidectomy in the wound bed to aid in haemostasis and to protect the facial nerve. Surgicel Original Haemostat (Ethicon) 0.5x2inch will be placed in the wound bed after parotidectomy by the treating surgeon prior to closing. The primary outcome will be formation of a sialocele post-operatively, quantified on ultrasound if a sialocele is clinically detected at the one week follow up. Secondary outcomes examined will include drain output, length of hospital stay and other post-operative complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71738 0
Dr Danielle Wiltshire
Address 71738 0
Ipswich Hospital
PO Box 73
IPSWICH QLD 4305
Country 71738 0
Australia
Phone 71738 0
+61 7 3810 1111
Fax 71738 0
Email 71738 0
[email protected]
Contact person for public queries
Name 71739 0
Dr Danielle Wiltshire
Address 71739 0
Ipswich Hospital
PO Box 73
IPSWICH QLD 4305
Country 71739 0
Australia
Phone 71739 0
+61 7 3810 1111
Fax 71739 0
Email 71739 0
[email protected]
Contact person for scientific queries
Name 71740 0
Dr Danielle Wiltshire
Address 71740 0
Ipswich Hospital
PO Box 73
IPSWICH QLD 4305
Country 71740 0
Australia
Phone 71740 0
+61 7 3810 1111
Fax 71740 0
Email 71740 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.