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Trial registered on ANZCTR


Registration number
ACTRN12623000278639
Ethics application status
Approved
Date submitted
10/01/2023
Date registered
15/03/2023
Date last updated
15/03/2023
Date data sharing statement initially provided
15/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
How Deep? - A randomised controlled trial into the surgical treatment of carbuncles
Scientific title
How deep - A randomised controlled trial comparing incision and drainage and conservative debridement versus conventional full thickness excision (saucerisation) for the surgical treatment of carbuncles in adults
Secondary ID [1] 308556 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carbuncle 328628 0
Condition category
Condition code
Skin 325632 325632 0 0
Dermatological conditions
Surgery 325715 325715 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm2:
Incision and Drainage and Conservative Debridement
Why:
Removal of carbuncle while maintaining deeper dermis
What:
Defined as incision and drainage of pus, removal of tissue but maintaining underling deeper dermis.
Who:
Surgeon trained in method of carbuncle removal
How:
Face-to-face (surgery)
Surgical procedure is roughly 20 minutes
Post surgery, patient surgical record is checked to confirm that it was: a) a carbuncle. b) the correct surgical method.
Where:
Royal Darwin Hospital operating theatre
When:
One session once admitted to Royal Darwin Hospital and randomised to arm of trial
Weekly wound reviews (photo and measuring) for 12 weeks to monitor wound healing.
Intervention code [1] 325167 0
Treatment: Surgery
Comparator / control treatment
Arm1:
Full Thickness Excision (Saucerisation)
Why:
Removal of carbuncle necrotic centre and surrounding cellulitis
What:
Defined as excision of all necrotic tissue possible, down to a healthy base.
Who:
Surgeon trained in method of carbuncle removal
How:
Face-to-face (surgery)
Surgical procedure is roughly 20 minutes
Post surgery, patient surgical record is checked to confirm that it was: a) a carbuncle. b) the correct surgical method.
Where:
Royal Darwin Hospital operating theatre
When:
One session once admitted to Royal Darwin Hospital and randomised to arm of trial
Weekly wound reviews (photo and measuring) for 12 weeks to monitor wound healing.
Control group
Active

Outcomes
Primary outcome [1] 333488 0
Time to wound healing of surgical wound, assessed by weekly wound review using Silhouette Camera (if patient is at Royal Darwin Hospital or a Telehealth satellite site equipped with Silhouette camera), or manual measurements (if patient is at site without Silhouette Camera)
Timepoint [1] 333488 0
Weekly for 12 weeks post-surgery
Secondary outcome [1] 417264 0
Requirement for skin grafts, assessed and monitored in weekly clinician wound reviews and dressing changes
Timepoint [1] 417264 0
Weekly for 12 weeks post-surgery
Secondary outcome [2] 417265 0
Return to theatre required, assessed and monitored in weekly clinician wound reviews and dressing changes
Timepoint [2] 417265 0
Weekly for 12 weeks post-surgery
Secondary outcome [3] 417266 0
Re-admission to hospital, Monitored and assessed using electronic medical record (Caresys).
Timepoint [3] 417266 0
12 weeks post-surgery
Secondary outcome [4] 417267 0
Length of hospital stay. Data gathered and recorded using electronic medical record (Caresys).
Timepoint [4] 417267 0
12 weeks post-surgery, etc.
Secondary outcome [5] 417268 0
Cosmetic satisfaction via qualitative survey designed for the study by the study team.
Timepoint [5] 417268 0
12 weeks post-surgery
Secondary outcome [6] 417269 0
Microbial epidemiology assessed using skin swab and culture, as well as intra-operative swab and culture of wound.
Timepoint [6] 417269 0
Intraoperatively and 12 weeks post-surgery

Eligibility
Key inclusion criteria
Once a diagnosis of carbuncle is confirmed, all patients except those who meet the exclusion criteria, will be informed of the standard surgical management, and offered the opportunity the participate in this Randomised Controlled Trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years of age.
Patients who are pregnant.
Patients who are breastfeeding.
Non-operative candidates due to anaesthetic risk and significant comorbidities.
Patients under Guardianship.
Patients under the Mental Health Act.
Patients not wishing 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)
Sealed Manila Folders
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation; randomisation based on a single sequence of random assignments.
Computerised sequence generation of simple randomisation sequence.
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
The sample size calculation is based on the primary outcome of healing time for Carbuncle patients in NT and is estimated based on an earlier case-based studies. In these studies, the average healing time difference between two methods was about 3 weeks with standard deviation 4 weeks. We assume that the same effect size would be observed in our trial. The estimated sample size would be 41 patients per arm to achieve 90% power of the study. A two-sided Wilcoxon Rank-Sum test was used to calculate the sample size assuming that the actual data distribution is normal when the significance level (alpha) of the test is 0.05 and the standard deviation is 4.0 in both groups. Assuming an attrition rate of 50%, the estimated sample size would be 124 patients in total or 62 per group. A PASS software was used to calculate the sample size.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/02/2022
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
23/02/2024
Actual
Sample size
Target
124
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 23777 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 39224 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 312804 0
Hospital
Name [1] 312804 0
Royal Darwin Hospital
Country [1] 312804 0
Australia
Primary sponsor type
Hospital
Name
Royal Darwin Hospital
Address
105 Rocklands Dr, Tiwi NT 0810
Country
Australia
Secondary sponsor category [1] 314446 0
None
Name [1] 314446 0
Address [1] 314446 0
Country [1] 314446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312089 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 312089 0
Ethics committee country [1] 312089 0
Australia
Date submitted for ethics approval [1] 312089 0
Approval date [1] 312089 0
12/01/2022
Ethics approval number [1] 312089 0
HREC 2021-4140

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123434 0
Dr Richard Bradbury
Address 123434 0
105 Rocklands Dr, Tiwi NT 0810 -- Royal Darwin Hospital
Country 123434 0
Australia
Phone 123434 0
+61 408975842
Fax 123434 0
Email 123434 0
richard.bradbury@nt.gov.au
Contact person for public queries
Name 123435 0
David Toro Tole
Address 123435 0
Giles St, Katherine NT 0850 -- Katherine District Hospital
Country 123435 0
Australia
Phone 123435 0
+61 416 143 928
Fax 123435 0
Email 123435 0
david.torotole@nt.gov.au
Contact person for scientific queries
Name 123436 0
David Toro Tole
Address 123436 0
Giles St, Katherine NT 0850 -- Katherine District Hospital
Country 123436 0
Australia
Phone 123436 0
+61 416 143 928
Fax 123436 0
Email 123436 0
david.torotole@nt.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
Data only needed for analyses done by research team on Epiinfo.


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.