MRSA-colonised community patients with "uncomplicated" venous leg ulcers scheduled to receive regular nursing care, for 12 to 15 weeks, will be considered for the study. NB: There is no intention to treat infection or the leg ulcer per se. The reason for using patients with uncomplicated venous leg ulcers is simply because these patients will require frequent nurse visits anyway, thereby allowing implementation of the study without unduly adding to the nurses' workload (eg extra visits).
Conditions
Interventions
Trade Name: Dermol 500 Lotion
Pharmaceutical Form: Cutaneous emulsion
Trade Name: Dermol 600 Bath Emollient
Pharmaceutical Form: Bath additive
Trade Name: Dermol Cream
Pharmaceutical Form: Cream
Sponsors
Dermal Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Adult community patients, aged 18 years or over who are considered, by the district nurse, unlikely to be unsettled by the possibility of being invited to take part in a clinical trial involving MRSA colonisation. ii) Patients with "uncomplicated" venous leg ulcers (ie no clinical suspicion of microbiological infection), requiring regular nursing treatment visits, for at least 15 weeks. iii) Patients who test positive for MRSA at the perineum and/or nares. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) Patients with clinical signs and symptoms of infection, and therefore requiring active antimicrobial pharmacotherapy. ii) Patients with a history of intolerance or skin sensitivity to any of the ingredients of the investigational products. iii) Patients who in the opinion of the district nurse may, for whatever reason, become unduly anxious about participating in such a study involving MRSA. iv) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medications during the period of the study. v) Mentally incapacitated patients who are considered by the District Nurse as being unable to perform the 'acceptability' assessments (physically incapacitated patients with appropriate homes care may be included). vi) Patients who are pregnant or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). vii) Patients with systemic diseases which, in the opinion of the investigator, may adversely influence their participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to demostrate whether use of the Dermol range of antimicrobial emollients and soap substitutes, in a multi-approach infection control strategy is more effective than using "best nursing practices" alone in eradicating MRSA colonisation, in community patients.;Secondary Objective: To investigate the safety profile and cosmetic acceptability of the Dermol products, used in this way.;Primary end point(s): Eradication of MRSA colonisation, as confirmed by three consecutive weekly sets (ie ulcer, perineum and nose) of negative MRSA microbiological screens after 12 weeks. | — |
Countries
United Kingdom
Outcome results
None listed