Efficacy of Local Powder Prophylactics
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ClinicalTrials.gov Identifier: NCT01372371 |
Recruitment Status : Unknown
Verified June 2011 by Ganga Hospital.
Recruitment status was: Recruiting
First Posted : June 13, 2011
Last Update Posted : June 13, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infection | Biological: Vancomycin Biological: Vancomycin and Gentamycin Biological: Cefuroxime | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1844 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effects of Applying Powdered Prophylactics Verses Intravenous Antibiotics Only on Post-operative Infection Rate |
Study Start Date : | June 2011 |
Estimated Primary Completion Date : | June 2012 |
Estimated Study Completion Date : | June 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Vancomycin |
Biological: Vancomycin
1 pre-operative dose of intravenous Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg) + 500 mg of vancomycin instilled on surgical site before closure |
Active Comparator: Vancomycin and Gentamycin |
Biological: Vancomycin and Gentamycin
1 pre-operative dose of intravenous Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg) and 500 mg of vancomycin powder on surgical site before closure with gentamycin bone cement for joint replacement cases. |
Active Comparator: Intravenous Antibiotic |
Biological: Cefuroxime
1 pre-operative dose of Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg) |
- Infection percent after surgery [ Time Frame: Within one year after surgery ]

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All joint replacement patients
- All non infected spine patients
- Hemiarthroplasty, All upper limb plating of closed fractures
Exclusion Criteria:
- Open injuries in trauma
- Revision joint replacement surgeries
- Patients with suspicion of existing infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372371
India | |
Ganga Hospital, Orthopaedics Department | Recruiting |
Coimbatore, Tamil Nadu, India, 641043 | |
Contact: Janardhan Yerramshetty, Ph.D. 0422-2485000 jyerram@gmail.com | |
Principal Investigator: Rajasekaran Shanmuganathan, Ph.D. |
Principal Investigator: | Rajasekaran Shanmuganathan, Ph.D. | Ganga Hospital |
Responsible Party: | Dr. S. Rajasekaran, Ph.D., Ganga Hospital |
ClinicalTrials.gov Identifier: | NCT01372371 |
Other Study ID Numbers: |
U1111-1119-9648 |
First Posted: | June 13, 2011 Key Record Dates |
Last Update Posted: | June 13, 2011 |
Last Verified: | June 2011 |
Vancomycin, Gentamycin Local Powder Antibiotic's Efficacy in Controlling Post Surgical Infection |
Infections Vancomycin Gentamicins Cefuroxime Cefuroxime axetil |
Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |