This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Pin Site Infection Prevention for Open Tibial Fracture

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

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
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

Resource links provided by NLM:

Further study details as provided by Prince of Songkla University:

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

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

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


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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: November 17, 2009
Last Updated: November 19, 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 processed this record on August 21, 2017