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Control of MRSA skin and wound colonisation.

Phase 1
Conditions
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).
Registration Number
EUCTR2006-005777-22-GB
Lead Sponsor
Dermal Laboratories
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
40
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

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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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