Pin Site Infection Prevention for Open Tibial Fracture

This study has been completed.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01017094
First received: November 17, 2009
Last updated: November 19, 2009
Last verified: November 2009

November 17, 2009
November 19, 2009
September 2007
June 2008   (final data collection date for primary outcome measure)
incidence of pin site infection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01017094 on ClinicalTrials.gov Archive Site
  • type of organism [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • severity of pin site infection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pin Site Infection Prevention for Open Tibial Fracture
Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Tibial Fracture
Drug: silversulfadiazine
apply once a day
Experimental: dry dressing
local application
Intervention: Drug: silversulfadiazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2009
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunocompromised patients (diabetes, HIV or malignancy)
Both
15 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01017094
EC 50/369-006
No
Secretariate,Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University
Prince of Songkla University
Not Provided
Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D Faculty of Medicine, Prince of Songkla University
Prince of Songkla University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP