Pin Site Infection Prevention for Open Tibial Fracture

Phase 3

Completed

• Conditions: Tibial Fracture
• Interventions: Drug: silversulfadiazine

• Registration Number: NCT01017094
• Lead Sponsor: Prince of Songkla University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-06
• Status Verified: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-19
• Last Update Submitted: 2009-11-19
• Study First Posted: 2009-11-20
• Last Update Posted: 2009-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Immunocompromised patients (diabetes, HIV or malignancy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dry dressing	silversulfadiazine	local application

Primary Outcome Measures

Name	Time	Method
incidence of pin site infection	2 years

Secondary Outcome Measures

Name	Time	Method
type of organism	2 years
severity of pin site infection	2 years

Trial Locations

Locations (1)

Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand