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Trial registered on ANZCTR


Registration number
ACTRN12618000767202
Ethics application status
Approved
Date submitted
6/04/2018
Date registered
7/05/2018
Date last updated
12/04/2019
Date data sharing statement initially provided
12/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised study to determine the wound healing of 2 different surgical incisions for patients undergoing surgical removal of the thyroid gland.
Scientific title
A Randomised, Blinded Clinical Trial of Scalpel vs Electrocautery Skin Incisions in Participants Undergoing Thyroid Surgery to Compare Cosmesis and Wound Healing
Secondary ID [1] 294517 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SEST Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid disorders 307289 0
Condition category
Condition code
Surgery 306406 306406 0 0
Surgical techniques
Metabolic and Endocrine 306774 306774 0 0
Thyroid disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the operating theatre, the patient will be in a supine position and after general anaesthesia with endotracheal intubation the neck will be hyper-extended by placing a sand-bag between shoulders; table titled to 30° anti-trendelenburg position.
After skin disinfection with suitable antiseptic (as determined by operating surgeon) and preparation of the sterile field, an adequate “collar” incision will be performed, at the level of cricoid bone with diathermy according to randomization. The diathermy incision will be performed using the cutting mode at 40. The operation will then proceed as per the operating surgeon’s usual technique.
Compliance to treatment allocation will be monitored by review of the operation report completed by the surgeon.
Intervention code [1] 300820 0
Treatment: Surgery
Comparator / control treatment
After skin disinfection with suitable antiseptic (as determined by operating surgeon) and preparation of the sterile field, an adequate “collar” incision will be performed, at the level of cricoid bone with the scalpel according to randomization.
Compliance to treatment allocation will be monitored by review of the operation report completed by the surgeon
Control group
Active

Outcomes
Primary outcome [1] 305421 0
The difference in cosmetic outcome between the scalpel and electrocautery groups using a Patient Observer Scar Assessment Scale (POSAS)
Timepoint [1] 305421 0
6 months post-operatively
Secondary outcome [1] 345129 0
Post-operative visual analolgue pain scores (o-10)
Timepoint [1] 345129 0
1 and 24 hours post-operatively
Secondary outcome [2] 345130 0
Surgical site infection as defined by the Centre for Disease Control (CDC in USA
Timepoint [2] 345130 0
Day 30 post-operatively
Secondary outcome [3] 345131 0
Opioid analsesic consumption during admission as recorded on medication chart in morphine milli-equivalents
Timepoint [3] 345131 0
to discharge from hospital
Secondary outcome [4] 346367 0
The difference in cosmetic outcome between the scalpel and electrocautery groups using a Patient Scar Assessment Scale (POSAS)
Timepoint [4] 346367 0
6 months post-operatively

Eligibility
Key inclusion criteria
All patients undergoing elective or semi-urgent booked total or hemithyroidectomy who provide written informed consent, having procedure at participating sites.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have undergone previous neck surgery or radiotherapy
Require lateral neck surgery
Unable to attend follow-up appointments with treating surgeon
Refuse or are unable to provide written consent to participate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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] 10578 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 22297 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 299142 0
Hospital
Name [1] 299142 0
John Hunter Hospital
Address [1] 299142 0
Lookout Rd
New Lambton Heights
NSW 2305
Country [1] 299142 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lookout Rd
New Lambton Heights
NSW 2305
Country
Australia
Secondary sponsor category [1] 298401 0
None
Name [1] 298401 0
NA
Address [1] 298401 0
NA
Country [1] 298401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300072 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 300072 0
Locked Bag 1
New Lambton
NSW 2305
Ethics committee country [1] 300072 0
Australia
Date submitted for ethics approval [1] 300072 0
27/02/2018
Approval date [1] 300072 0
03/05/2018
Ethics approval number [1] 300072 0
2018/ETH00013

Summary
Brief summary
The study is being done to compare to 2 methods of incision ( a surgical cut to the skin and tissue) in patients undergoing surgical removal of part or all of the thyroid gland.:
1. Using a scalpel (cutting skin and tissue with a metal blade) or
2. Electrocautery (also known as diathermy, a method of cutting skin and tissue using heat).
The researchers want to find out which of these procedures can make the quickest incision, the best cosmetic outcome (the best looking scar), is least painful for the participant and heals the best.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82474 0
Dr Cino Bendinelli
Address 82474 0
Surgical Services
John Hunter Hospital
Lookout Rd
New Lambton Heights NSW 2305
Country 82474 0
Australia
Phone 82474 0
+61 2 49855153
Fax 82474 0
Email 82474 0
cino.bendinelli@hnehealth.nsw.gov.au
Contact person for public queries
Name 82475 0
Ms Rosemary Carroll
Address 82475 0
Surgical Services
John Hunter Hospital
Lookout Rd
New Lambton Heights NSW 2305
Country 82475 0
Australia
Phone 82475 0
+61 2 49855153
Fax 82475 0
Email 82475 0
HNELHD-SurgeryResearch@health.nsw.gov.au
Contact person for scientific queries
Name 82476 0
Dr Cino Bendinelli
Address 82476 0
Surgical Services
John Hunter Hospital
Lookout Rd
New Lambton Heights NSW 2305
Country 82476 0
Australia
Phone 82476 0
+61 2 49855153
Fax 82476 0
Email 82476 0
HNELHD-SurgeryResearch@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved by HREC as yet for this.
What supporting documents are/will be available?
No other documents available
Summary results
No Results