Pin Site Infection Prevention for Open Tibial Fracture
This study has been completed.
Sponsor:
Prince of Songkla University
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
| Tracking Information | |||||
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| First Received Date ICMJE | November 17, 2009 | ||||
| Last Updated Date | November 19, 2009 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
incidence of pin site infection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01017094 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pin Site Infection Prevention for Open Tibial Fracture | ||||
| Official Title ICMJE | Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Tibial Fracture | ||||
| Intervention ICMJE | Drug: silversulfadiazine
apply once a day |
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| Study Arm (s) | Experimental: dry dressing
local application
Intervention: Drug: silversulfadiazine |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | November 2009 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01017094 | ||||
| Other Study ID Numbers ICMJE | EC 50/369-006 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Secretariate,Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University | ||||
| Study Sponsor ICMJE | Prince of Songkla University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Prince of Songkla University | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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