Pin Site Infection Prevention for Open Tibial Fracture

• Sponsor: Prince of Songkla University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01017094
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tibial Fracture	Drug: silversulfadiazine	Phase 3

Study Design

• Study Type: Interventional
• 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: Sep 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. incidence of pin site infection [2 years]

Secondary Outcome Measures

1. type of organism [2 years]

2. severity of pin site infection [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 60 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01017094
• Other Study ID Numbers: EC 50/369-006
• First Posted: Nov 20, 2009
• Last Update Posted: Nov 20, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Pin-site infection; silversulfadiazine; open fracture; open tibial fracture underwent external fixator
• Additional relevant MeSH terms: Infections; Fractures, Bone; Tibial Fractures; Silver Sulfadiazine

Study Results

No Results Posted as of Nov 20, 2009