None listed
Conditions
Brief summary
The aim of the clinical trial is to determine if the novel Moisturising Skin Support is as effective or more effective in managing chronic wounds than standard care (sorbolene cream) when used by wound care nurses within the pharmacy setting over a 3 year period. The hypothesis is that the novel moisturising skin support will be as more effective than standard treatment in managing chronic wounds,
Interventions
Interventional study of a novel moisturising skin support versus standard care. The treatment is provided as an alternative wound care treatment to the standard chronic wound care currently being applied in wound care clinics. The Application of treatment in performed by wound care nurses at time of bandage change, usually 7-19 days apart, for a period of up to 3 years, at the medical centre.
The treatment is a topical (cream product) that also has a sorbolene base cream.
The investigational pro
Interventional study of a novel moisturising skin support versus standard care. The treatment is provided as an alternative wound care treatment to the standard chronic wound care currently being applied in wound care clinics. The Application of treatment in performed by wound care nurses at time of bandage change, usually 7-19 days apart, for a period of up to 3 years, at the medical centre. The treatment is a topical (cream product) that also has a sorbolene base cream. The investigational product is a combination of two novel active proprietary ingredients in a cream; at 5% Papaya and 2% Palmidrol (both are on the TGA permitted ingredients list) as well as sorbolene. The intervention (cream) is applied at a clinic appointment so the process for monitoring adherence to the intervention is performed at each bandage change by the wound care nurses.
Sponsors
Optiderma Biosciences Pty. Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible for inclusion, the participant must fulfill the following criteria: • Written informed consent • Stated availability for attending the pharmacy for regular dressing changes as required (for up to 3 years; or to healed). • Provided permission for photographs of the wound (no other identifying information in the photograph) and wound assessment by the wound nurse at the time of the change of dressing, and completion of a daily record diary (between changes in dressings)
Exclusion criteria
The presence of any of the following criteria will exclude the participant from participating in the study: Any clinically relevant abnormal findings which, in the opinion of the pharmacists and general practitioners that may put the participant at risk of adverse events because of participation in the clinical trial
Outcome results
None listed