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Trial registered on ANZCTR


Registration number
ACTRN12620001062910
Ethics application status
Approved
Date submitted
7/08/2020
Date registered
16/10/2020
Date last updated
16/10/2020
Date data sharing statement initially provided
16/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Red Light Therapy for pilonidal sinus wounds- a pilot study
Scientific title
Assessing wound healing outcomes of photobiomodulation therapy in patients admitted to Hospital In The Home (HITH) for post-surgical treatment of pilonidal sinus wounds – a feasibility study
Secondary ID [1] 300495 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pilonidal sinus wounds 316176 0
Condition category
Condition code
Surgery 314473 314473 0 0
Other surgery
Skin 316939 316939 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of standard wound dressings for pilonidal sinus wounds for wounds deemed by the parent unit requiring hospital in the home wound treatment, and standard wound dressing for pilonidal sinus wounds plus shining of red light from LED directly onto the wound for 60 -90 seconds daily for 2 weeks or until the wound is ready for discharge which ever comes sooner. There are 10 patients in the treatment group and 5 in the control group.
The length of wound determines the length of time the red light therapy is given so for wound less than 4 cm then the wound is divided into 2 parts each receiving 30 seconds of light treatment and for wounds greater than 4cm then the wound is divided into 3 parts and each section is treated for 30 seconds for a total time of 90 seconds to the wound. The light therapy will be done by the HITH nurses who are allocated to see the patient that day, the research nurse will only administer the light on the day that they are measuring and photographing the wound.
Adherence will be documented in the notes by the HITH nurses who see the patient.
The standard wound dressings clean the wound with normal saline then apply aquacel rope as the primary dressing (a hydrocolloid fibre dressing)and then apply zetuvite as the secondary dressing.
Intervention code [1] 316806 0
Treatment: Devices
Comparator / control treatment
The patients in the control group who will receive standard care wound dressings which consists of cleaning of the wound with saline and then daily aquacel as the primary dressing and zetuvite as the secondary dressing. The wound dressings will be administered by the Monash Health HITH nurses, the research nurse will do the measurements and take photographs and if needed the dressings on those days but otherwise the HITH nurses who would routinely do the dressings will be doing the dressings.
Control group
Active

Outcomes
Primary outcome [1] 322833 0
Protocol adherence
Nursing notes
Timepoint [1] 322833 0
6 months from recruitment of 1st patient
Secondary outcome [1] 379961 0
proportion of participants that reach 50 % reduction in wound surface area
The patients will have their wounds measured weekly by the clinical project managers ( 2 specified individuals) as well as having photos taken weekly. The measurements will by done manually.
Timepoint [1] 379961 0
Patient's will have the wound measured and photographed at one week after after admission to Monash HITH unit and then again at 2 weeks, if the patient is to be discharged before this time then measurements and photos will be taken at that time.

Eligibility
Key inclusion criteria
• Aged 18 years and over.
• Pilonidal sinus wound first surgical management with surgical debridement and healing by
secondary intention.
• Requires daily passive dressings that would normally require referral to Monash HITH.
• Able to understand the plain language summary and competent to make informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women who are pregnant.
• Patients on immunosuppressant drugs including corticosteroids.
• People with a diagnosis of cancer; dementia, severe mental illness or any other condition that may significantly reduce the ability to consent or fully undertake the program and/or that may adversely affect clinical risk.
• Previous participation in the trial.
• Participant’s primary clinician unwilling to enrol patient in the trial.
• Undermining of wound greater than 2cm and depth greater than 5cm.
• Patient unwilling to participate.
• Unable to understand the plain language summary and to make informed consent.

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
Not yet 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)
VIC

Funding & Sponsors
Funding source category [1] 304884 0
Charities/Societies/Foundations
Name [1] 304884 0
The HITH society Australasia Ltd
Address [1] 304884 0
HITH society of Australasia
54 Churchill Road Prospect
South Australia 5082
Country [1] 304884 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd, Level 1, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 305223 0
None
Name [1] 305223 0
Address [1] 305223 0
Country [1] 305223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305299 0
Monash Health HREC
Ethics committee address [1] 305299 0
Research support services,
Monash Health Level 2,I Block, Monash Medical Centre, 246 Clayton Rd, Clayton 3168 Victoria
Ethics committee country [1] 305299 0
Australia
Date submitted for ethics approval [1] 305299 0
08/11/2019
Approval date [1] 305299 0
24/07/2020
Ethics approval number [1] 305299 0

Summary
Brief summary
This research study is looking at the effects of photobiomodulation ( Photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons) on healing of pilonidal sinus wounds healing after surgical debridement. As this is a pilot study it is a feasibility study into wether we have correctly set up the parameters for this project so a larger study can take place which will have more statistical significance.
We are using a small LED torch which produces a 660 nm wavelength and shining the light directly onto the wound for a period of 60 -90 seconds in those patients who have been referred to Hospital in the Home for complex wound management. The length of time is determined by the size of the wound, 90 seconds for wounds longer than 4 cm and 60 seconds for wounds 4cm or less. The plan is for having a control group and a treatment group both will receive the same standard dressing care regime but the treatment group will additionally have the light treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99906 0
Dr Duncan Syme
Address 99906 0
Dandenong Hospital
Hospital in the Home
135 David St
Dandenong 3175
Victoria
Country 99906 0
Australia
Phone 99906 0
+61 3 95948781
Fax 99906 0
+61 3 95948988
Email 99906 0
duncan.syme@monashhealth.org
Contact person for public queries
Name 99907 0
Dr Duncan Syme
Address 99907 0
Dandenong Hospital
Hospital in the Home
135 David St
Dandenong 3175
Victoria
Country 99907 0
Australia
Phone 99907 0
+61 3 95948781
Fax 99907 0
+61 3 95948988
Email 99907 0
duncan.syme@monashhealth.org
Contact person for scientific queries
Name 99908 0
Dr Duncan Syme
Address 99908 0
Dandenong Hospital
Hospital in the Home
135 David St
Dandenong 3175
Victoria
Country 99908 0
Australia
Phone 99908 0
+61 3 95948781
Fax 99908 0
+61 3 95948988
Email 99908 0
duncan.syme@monashhealth.org

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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7023 0
Study protocol
Citation [1] 7023 0
Link [1] 7023 0
Email [1] 7023 0
Other [1] 7023 0
Contact the Principal Investigator
Dr Duncan Syme
Monash Health
Dandenong Hospital HITH unit 135 David St Dandenong 3175 Victoria Australia
phone 03 9554 8781 or switch 03 9594 6666
Attachment [1] 7023 0
Type [2] 8637 0
Informed consent form
Citation [2] 8637 0
Link [2] 8637 0
Email [2] 8637 0
Other [2] 8637 0
Contact the Principal Investigator
Dr Duncan Syme
Monash Health
Dandenong Hospital HITH unit 135 David St Dandenong 3175 Victoria Australia
phone 03 9554 8781 or switch 03 9594 6666
Attachment [2] 8637 0
Type [3] 8638 0
Ethical approval
Citation [3] 8638 0
Link [3] 8638 0
Email [3] 8638 0
Other [3] 8638 0
Contact the Principal Investigator
Dr Duncan Syme
Monash Health
Dandenong Hospital HITH unit 135 David St Dandenong 3175 Victoria Australia
phone 03 9554 8781 or switch 03 9594 6666
Attachment [3] 8638 0
Summary results
No Results