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OpenTrials
Completed

NCT Number: NCT01017094

Pin Site Infection Prevention for Open Tibial Fracture

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.

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Key information

Conditions

Tibial Fracture Fractures, Bone Fractures, Open Leg Injuries Tibial Fractures Wounds and Injuries

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Immunocompromised patients (diabetes, HIV or malignancy)

Treatment and study plan

silversulfadiazine

Drug

apply once a day

Primary outcomes

  1. incidence of pin site infection

    Time frame: 2 years

Secondary outcomes

  1. type of organism

    Time frame: 2 years

  2. severity of pin site infection

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 20, 2009
Registry last updated
Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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