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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
Sponsor:
Information provided by:
Ganga Hospital

Brief Summary:
Hypothesis: Directly applying antibiotic powder onto the site of surgery along with perioperative intravenous antibiotics, before closing the wound, is more effective than intravenously applied perioperative antibiotics alone in controlling post-operative wound infection. The investigators also think powders that control both gram positive and gram negative bacteria are more beneficial.

Condition or disease Intervention/treatment Phase
Infection Biological: Vancomycin Biological: Vancomycin and Gentamycin Biological: Cefuroxime Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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)




Primary Outcome Measures :
  1. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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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.         
Sponsors and Collaborators
Ganga Hospital
Investigators
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Principal Investigator: Rajasekaran Shanmuganathan, Ph.D. Ganga Hospital
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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
Keywords provided by Ganga Hospital:
Vancomycin, Gentamycin
Local Powder Antibiotic's Efficacy in Controlling Post Surgical Infection
Additional relevant MeSH terms:
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Infections
Vancomycin
Gentamicins
Cefuroxime
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action