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NCT01017094
Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial
Phase 3 trial testing silversulfadiazine in Tibial Fracture in 30 participants. Completed in 1 November 2009.
1 June 2008
Quick facts
| Lead sponsor | Prince of Songkla University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 September 2007 |
| Primary completion | 1 June 2008 |
| Estimated completion | 1 November 2009 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- silversulfadiazine — full drug profile →
Conditions studied
- Tibial Fracture — all drugs for Tibial Fracture →
Sponsor
Prince of Songkla University
Who can join
Adults 15 to 60, any sex, with Tibial Fracture. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
incidence of pin site infection
Time frame: 2 years
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01017094
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Tibial Fracture
Currently open trials in the same condition.
- NCT03598530 — Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures · active not recruiting
Other Prince of Songkla University trials
Trials by the same sponsor.
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- NCT07245966 — Pharmacokinetics and Pharmacodynamics of High Dose Ceftriaxone in Patients With Sepsis · completed
- NCT06265870 — Specific Versus Empirical Anthelminthic Treatment in Eosinophilia · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01017094 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prince of Songkla University
- Last refreshed: 19 November 2009
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01017094.
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