None listed
Conditions
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.
Interventions
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
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.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed