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Pin Site Infection Prevention for Open Tibial Fracture

Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01017094
Enrollment
30
Registered
2009-11-20
Start date
2007-09-30
Completion date
2009-11-30
Last updated
2009-11-20

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

Conditions

Tibial Fracture

Keywords

Pin-site infection, silversulfadiazine, open fracture, open tibial fracture underwent external fixator

Brief summary

This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing. Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.

Interventions

DRUGsilversulfadiazine

apply once a day

Sponsors

Prince of Songkla University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Open tibial fracture treated with external fixator age between 15-60 years

Exclusion criteria

* Immunocompromised patients (diabetes, HIV or malignancy)

Design outcomes

Primary

MeasureTime frame
incidence of pin site infection2 years

Secondary

MeasureTime frame
type of organism2 years
severity of pin site infection2 years

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026