ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000002280

Ethics application status

Approved

Date submitted

21/11/2017

Date registered

8/01/2018

Date last updated

29/06/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Feasibility of using PROMOGRAN PRISMA® on leg ulcers that are slow to heal

Scientific title

Feasibility of using PROMOGRAN PRISMA® on stalled venous and stasis leg wounds

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1205-4567

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

venous leg ulcer

Stasis leg ulcer

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Venous or stasis leg ulcers that are slow to healed (defined as having care meeting Standard of Care (appropriate wound bed preparation and compression therapy) for at least 4 weeks), and the wound size reduced by less than 30% over 4 weeks) will be treated with PROMOGRAN PRISMA®, a silver eluting cellulose/collagen matrix (ARTG # 197114), weekly for 6 weeks in conjunction with Standard of Care. PROMOGRAN PRISMA® matrix is a thin film in appearance. The matrix will be applied directly to the surface of the wounds, and will be cut to cover the entire wound surface area with the amount of matrix applied dependent on wound size. The matrix absorbs moisture from the wound and over time will be absorbed and does not require removal.
Patients will visit the wound clinic study sites on week 1 (first application of PROMOGRAN PRISMA®) 3, 5, 6 and week 12, and matrix will be applied by wound care nurses at the sites on week 1, 3 and 5. At week's 2 and 4 the usual care provider for the patient's wound will apply the matrix as part of standard dressing changes which include replenishing the primary dressing (PROMOGRAN PRISMA®) and secondary dressings (variable depending on clinical need) and associated compression. The usual care provider may be the patient, a carer/family member or community/facility/general practice nurse/or wound clinic nurse depending on individual circumstances. Instruction on how to apply the matrix at dressing changes will be provided verbally and written instructions provided along with matrix for the dressing change. At visits on week 3 and 5 patients will be asked if PROMOGRAN PRISMA® was reapplied as planned at week 2 and 4, and reasons for non-adherence recorded.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

No control group. Rate of wound healing will be compared to rate during 4 weeks prior to treatment with intervention.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of recruitment and study procedures determined from the number of patients recruited within four months and number of patients completing study by June 2018.

Timepoint [1]

Four months (recruitment), to 30 June 2018 (completion)

Secondary outcome [1]

Healed ‘study wound’ at 12 weeks (yes/no) defined as 100% epithelisation/wound closure as assessed by treating clinician

Timepoint [1]

12 weeks

Secondary outcome [2]

Change in perceived wound pain with time measured using visual analogue pain scale

Timepoint [2]