None listed
Conditions
Brief summary
This is a cluster randomised trial of a novel skin preparation, OPAL X Wound Healing Cream, It is based in multiple aged care facilities within a statewide, church-based Aged Care provider. The comparator will be the standard moisturising cream currently in use at each facility. Randomisation will be by facility to minimise disruption to the routines of each facility by the research process. This is a pilot trial prior to a full trial. The hypotheses of the full trial will be: That OPAL X cream used as the moisturiser in best practice wound management regimes, vs standard moisturising creams will: 1. have reduced time to full healing.for acute wounds (like skin tears); 2 have reduced time to full healing.for chronic wounds (like skin ulcers); 3. Reduce the incidence rate of new skin tears on the affected limb 3. Generate improved quality of the undamaged skin of the affected limb. All people will be approached to participate, but only people with existing chronic wounds at enrolment, or who develop an acute skin injury in the first 2 months or until the target number of wounds is reached.
Interventions
Use of a commercially developed skin product - OPAL X to be applied on the skin around wound at change of wound dressing to a width of 2cm around the edge of the wound and rubbed in to the skin until no excess is left on the skin. The dose will vary depending on the size of the wound. For a lesion 5 cm in diameter the dose will be approximately 1/2 a fingertip unit (FTU)
The cream will be applied at each dressing change until the wound is healed, or up to 12 weeks, whichever is the lesser. I
Use of a commercially developed skin product - OPAL X to be applied on the skin around wound at change of wound dressing to a width of 2cm around the edge of the wound and rubbed in to the skin until no excess is left on the skin. The dose will vary depending on the size of the wound. For a lesion 5 cm in diameter the dose will be approximately 1/2 a fingertip unit (FTU) The cream will be applied at each dressing change until the wound is healed, or up to 12 weeks, whichever is the lesser. In addition, it will be applied twice daily to the affected limb for 12 weeks after the onset of treatment. (Testing the objectives of 1) whether OPAL X reduces the incidence of new skin tears compared with standard skin moisturising creams; and 2) whether regular use of OPAL X improves underlying skin quality compared with regular use of standard moisturising creams.) Adherence is being monitored via a form devised for the trial to be completed with each dressing change, OPAL applied to the whole affected limb twice daily for the duration of wound care until wound healing (normal best practice for wounds of any type).. Unused creams will be returned to the study manager at the end of 12 weeks,
Sponsors
OPAL X Therapeutics Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All residents of each aged care facility not excluded (see below) will be recruited to the study. Only those who develop an acute wound during the first two months, or those who come in to the study ( ie- pre-existing acute or chronic wounds) will be treated, The reason for this is to ensure that wound management is started promptly after the wound occurs, and not delayed by the process of achieving informed consent from either the resident themselves or their Enduring Guardian.
Exclusion criteria
1. Allergies to papaya pulp, skin or seeds 2. Severe, active peripheral vascular disease 3. end stage heart failure 4. Taking warfarin or second generation anticoagulant medicines (Direct anticoagulant therapy or non-potassium anticoagulant therapy)
Outcome results
None listed