Pin Site Infection Prevention for Open Tibial Fracture

Tibial Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017094
• Other study ID #: EC 50/369-006
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2009
• Last updated: November 19, 2009
• Start date: September 2007
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Immunocompromised patients (diabetes, HIV or malignancy)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fracture
• Tibial Fractures

Intervention

Drug:
• silversulfadiazine
apply once a day

Locations

Country	Name	City	State
Thailand	Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of pin site infection		2 years	Yes
Secondary	type of organism		2 years	Yes
Secondary	severity of pin site infection		2 years	Yes