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Pin Site Infection Prevention for Open Tibial Fracture

Primary Purpose

Tibial Fracture

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

silversulfadiazine

About this trial

This is an interventional treatment trial for Tibial Fracture focused on measuring Pin-site infection, silversulfadiazine, open fracture, open tibial fracture underwent external fixator

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Immunocompromised patients (diabetes, HIV or malignancy)

Sites / Locations

Prince of Songkla University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dry dressing

Arm Description

local application

Outcomes

Primary Outcome Measures

incidence of pin site infection

Secondary Outcome Measures

type of organism

severity of pin site infection

Full Information

NCT ID

NCT01017094

First Posted

November 17, 2009

Last Updated

November 19, 2009

Sponsor

Prince of Songkla University

1. Study Identification

Unique Protocol Identification Number

NCT01017094

Brief Title

Pin Site Infection Prevention for Open Tibial Fracture

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Prince of Songkla University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tibial Fracture

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dry dressing

Arm Type

Experimental

Arm Description

local application

Intervention Type

Drug

Intervention Name(s)

silversulfadiazine

Intervention Description

apply once a day

Primary Outcome Measure Information:

Title

incidence of pin site infection

Time Frame

2 years

Secondary Outcome Measure Information:

Title

type of organism

Time Frame

2 years

Title

severity of pin site infection

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Open tibial fracture treated with external fixator age between 15-60 years Exclusion Criteria: Immunocompromised patients (diabetes, HIV or malignancy)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boonsin Tangtrakulwanich, MD.,Ph.D

Organizational Affiliation

Faculty of Medicine, Prince of Songkla University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prince of Songkla University

City

Hat Yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Pin Site Infection Prevention for Open Tibial Fracture

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