A trial comparing two types of pin site care for circular frame patients
Phase 1
- Conditions
- Pinsite infectionTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-002223-10-GB
- Lead Sponsor
- Hull and East Yorkshire Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 118
Inclusion Criteria
Patients aged >16yrs
Fracture tibia
Circular frame surgery chosen
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
•Children (less than 16 years of age)
•Prisoners
•Dementia or cognitive impairment co-morbidity
•Known sensitivity to chlorhexidine / Dermol
•Have been involved in another CTIMP within the past 4 weeks
•Patients who would be unable to follow the pin site regime.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Are there any risk factors that can be identified to predict which patients are going to develop pinsite infections following circular frame surgery?;Primary end point(s): The primary outcome measure is the incidence of pin site infections amongst the two groups.;Timepoint(s) of evaluation of this end point: The endpoint is when the circular frame is removed;Main Objective: Does the use of an emmolient help protect the skin against pinsite infections following circular frame surgery?
- Secondary Outcome Measures
Name Time Method