PluroGel and leg ulcers
Research type
Research Study
Full title
A pilot randomised study to investigate the efficacy of PluroGel in healing venous and mixed aetiology leg ulcers
IRAS ID
208867
Contact name
Jonathan Primer
Contact email
Sponsor organisation
Medline Industries, Inc
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
This study will compare the effect of a new dressing, PluroGel, with Intrasite Gel dressing, when used with standard treatment on 40 patients with a venous or mixed venous arterial leg ulcer. \n\nPluroGel is a wound dressing that creates a moist environment at the wound surface and help to clean and debride (remove dead tissue) the wound.\n\nIntrasite Gel is a wound dressing gel that contains 85% water, and gently increases the moisture level within the wound using the body’s own enzymes and moisture to re-hydrate, soften and finally liquefy dead tissue (slough). \n\nParticipants will be asked to visit the research centre in their UHB once a week for 3 weeks (weeks 0,1,2) on their third visit, if the target wound has reduced in surface area by 30% or more and there has been a more than 25% reduction in slough, their participation in the study will end. For all 3 visits they will receive exactly the same treatment as they are receiving in the NHS clinic. \n\nHowever, if suitable at their third visit they will be randomised to the treatment phase, 20 to receive PluroGel and 20 to receive Intrasite Gel. \n\nTreatment Phase\nPatients will be asked to visit the research facility on twice more in Week 2, and 3 days a week for a further 3 weeks. On Week 2 and each following visit they will have their wound dressing taken down, wound cleansed, assessed and redressed with the dressing to which they were randomised. On the first visit each week the wound will also be photographed and measured (including randomisation week).\n\nThe primary endpoints are reduction in wound area over the 4 week treatment period and change in the percentage of slough covering the wound. The secondary endpoints are patient comfort, patient and staff acceptance of the hydrogel.
Summary of Results
No target wound healed during the four-week active treatment phase.
All bar one participant showed reductions in the surface area of their target wound between weeks 2 and 6.
Between weeks 2 and 6 the majority of target wounds showed reduced slough and necrotic tissue within the wound bed (7/8 reduced with PluroGel treatment, 6/8 reduced with Intrasite treatment.
Self-reported wound pain scores reduced in 13/16 participants between weeks 2 and 6.
No statistically significant differences were found between the responses of participants treated with PluroGel or Intrasite in terms of self reported quality of life.
Nursing staff reported that Intrasite was easy or very easy to apply, however in 5/8 participants the application of PluroGel was considered to be difficult. All found both treatments to be easy or very easy to remove.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0003
Date of REC Opinion
14 Feb 2017
REC opinion
Further Information Favourable Opinion