A trial comparing two types of pin site care for circular frame patients

A randomised controlled trial of a new daily skincare regimen for lowering the incidence of pinsite infections following circular frame surgery - Pinsite Infection In Circular Frames - PINS trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002223-10-GB

Enrollment

118

Registered

2014-12-22

Start date

2015-02-11

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pinsite infection

Interventions

Trade Name: Dermol Product Name: Dermol 500 Pharmaceutical Form: Cream INN or Proposed INN: Benzalkonium Chloride Concentration unit: %

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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?	—

Measure

Time frame

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?

—

Countries

United Kingdom

Contacts

Public ContactHemant Sharma

Hull & East Yorkshire NHS Trust

hemant.sharma@hey.nhs.uk01482875875

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026