Pin Site Infection Prevention for Open Tibial Fracture

NCT ID: NCT01017094

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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Tibial Fracture

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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dry dressing

local application

Group Type EXPERIMENTAL

silversulfadiazine

Intervention Type DRUG

apply once a day

Interventions

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silversulfadiazine

apply once a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Immunocompromised patients (diabetes, HIV or malignancy)
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Faculty of Medicine, Prince of Songkla University

Principal Investigators

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Boonsin Tangtrakulwanich, MD.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Prince of Songkla University

Locations

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Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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EC 50/369-006

Identifier Type: -

Identifier Source: org_study_id