None listed
Conditions
Brief summary
This study will compare the effectiveness of two different ways of treating leg ulcers that are infected or slow to heal. The treatments being compared are cadexomer iodine (Iodosorb® product range), and a silver impregnated dressing (Acticoat® product range). It is hypothesised that one of these treatments will lead to quicker healing and reduced cost compared to the other commonly used dressing.
Interventions
Cadexomer iodine dressing (Iodosorb)
Cadexomer iodine dressing (Iodosorb) is applied topically to the wounds. It is delivered according to the Iodosorb instructions for the wound whilst signs of infection and critical colonisation are evident in the wound. This time period may vary from wound to wound. The criteria for removing the client from the antimicorbial is consistent in the Iodosorb conditions. All participants will be monitored for a three month period.
Within the approved Iodosorb ra
Cadexomer iodine dressing (Iodosorb) Cadexomer iodine dressing (Iodosorb) is applied topically to the wounds. It is delivered according to the Iodosorb instructions for the wound whilst signs of infection and critical colonisation are evident in the wound. This time period may vary from wound to wound. The criteria for removing the client from the antimicorbial is consistent in the Iodosorb conditions. All participants will be monitored for a three month period. Within the approved Iodosorb range of products the following dressings would be applied with the following frequency though clinical judgement is permited to alter this scheduled dependent on the wound characteristics (for instance to more frequent dressing changes for highly exudating wounds) Idosorb Powder (9m/g Iodine) - three daily Iodosorb Paste (0.9%w/w Iodine Ph. Eur) - three daily Potentially a study participant could become eligible to cease an antimicrobial 1 week and 1 day after commencing the trial as a minimum time they could receive the treatment with the maximum time a person could receive an antimicrobial being the full three month study period or 12 weeks.
Sponsors
The Angior Family Foundation
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
Has a Lower Leg Ulcer (not Pressure Ulcer) with Ankle Brachial Pressure Index (ABPI) of .6 or above Has a wound which must be the major wound and is 15cms or less in diameter.
Exclusion criteria
Client has been on a course of topical antiseptic treatment in the 1 week prior to recruitment Client has been using any antibiotics (e.g. topical, IV, IM, oral) for either wound or other condition 48 hours prior to recruitment Client is using systemic steroids (e.g. oral, IM, IV, rectal). Client has a diagnosis of diabetesClient has a diagnosis of malignancy related to the leg ulcerClient is receiving palliative careClient has a contraindication to either treatment products.
Outcome results
None listed