Pin Site Infection Prevention for Open Tibial Fracture

Prince of Songkla University

Status and phase: Completed; Phase 3

Conditions: Tibial Fracture

Treatments: Drug: silversulfadiazine

Study type: Interventional

Funder types: Other

Identifiers

NCT01017094

EC 50/369-006

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Immunocompromised patients (diabetes, HIV or malignancy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 1 patient group

dry dressing

Experimental group

Description:

local application

Treatment:

Drug: silversulfadiazine