Pin Site Infection Prevention for Open Tibial Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01017094
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : November 20, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Tibial Fracture Drug: silversulfadiazine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial
Study Start Date : September 2007
Primary Completion Date : June 2008
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: dry dressing
local application
Drug: silversulfadiazine
apply once a day

Primary Outcome Measures :
  1. incidence of pin site infection [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. type of organism [ Time Frame: 2 years ]
  2. severity of pin site infection [ Time Frame: 2 years ]

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunocompromised patients (diabetes, HIV or malignancy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017094

Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D Faculty of Medicine, Prince of Songkla University

Responsible Party: Secretariate,Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University Identifier: NCT01017094     History of Changes
Other Study ID Numbers: EC 50/369-006
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: November 20, 2009
Last Verified: November 2009

Keywords provided by Prince of Songkla University:
Pin-site infection
open fracture
open tibial fracture underwent external fixator

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries
Silver Sulfadiazine
Anti-Infective Agents, Local
Anti-Infective Agents