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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
History of Changes
  Purpose

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 Intervention Phase
Tibial Fracture
 Drug: silversulfadiazine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • incidence of pin site infection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: November 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dry dressing
local application
 Drug: silversulfadiazine
apply once a day

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunocompromised patients (diabetes, HIV or malignancy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017094

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

No publications provided

Responsible Party: Secretariate,Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017094     History of Changes
Other Study ID Numbers: EC 50/369-006
Study First Received: November 17, 2009
Last Updated: November 19, 2009
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
Pin-site infection
silversulfadiazine
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013