None listed
Conditions
Brief summary
Venous leg ulcers and stasis ulcers are chronic wounds associated with poor circulation in the leg. Despite treatment some of these wounds fair to heal, or persist over many weeks, months or years. This pilot study aims to assess feasibility of a larger study investigating the use of a silver eluting cellulose/collagen matrix (PROMOGRAN PRISMA®) on hard to treat wounds. Patients with venous leg or stasis ulcers that is slow to heal will be treated with PROMOGRAN PRISMA® in conjunction with compression therapy and standard wound care weekly for 6 weeks, and followed up for a further 6 weeks. The study will measure the number of patients recruited in a 4-month period, number of patients competing the study, number of healed wounds after 12 weeks of follow up, wound surface area reduction over 12 weeks, change in percentage of the wound covered by slough, change in ankle and calf measurements and the amount of pain patients have at clinic visits.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
Male/female participants who are at least 18 years of age on the day of signing informed consent with chronic wounds treated at the study sites for four weeks after Standard of Care for the patient has been fully implemented. • Have a venous or stasis leg ulcer that has reduced in size by less than 30% over the previous 4 weeks • Do not have signs of clinical infection as defined by the International Wound Infection Institute (IWII) (Wound infection in clinical practice, 2016) as having the ‘presence of microbes in sufficient numbers or virulence to cause a host response locally or systemically’ • Are intending to continue to attend the study sites for wound care • Are able to comply with study procedures including attending study sites for visits and following study procedures for dressing changes between study site visits • Consent to wound images collected as part of Standard of Care for the four weeks prior to enrolment in the study being used to calculate pre-enrolment healing rate.
Exclusion criteria
• Known sensitivity to silver • Known sensitivity to collagen • Known sensitivity to Organic Regenerated Cellulose • Unable to consent due to cognitive impairment or language limitations preventing understanding of provided information and hence capacity for informed consent. • Uncontrolled systemic infection at time of recruitment as defined as the infection affecting the entire body with microorganisms spreading via the lymphatic and vascular systems in the body • Patients with a life expectancy of less than six months in the opinion of the treating investigator • Patients where the Care Objective for the wound is palliative with no expectation that the wound will heal • Active vasculitis • Full thickness burn injuries