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Efficacy of Local Powder Prophylactics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Ganga Hospital.
Recruitment status was:  Recruiting
Information provided by:
Ganga Hospital Identifier:
First received: June 10, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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 Intervention
Infection Biological: Vancomycin Biological: Vancomycin and Gentamycin Biological: Cefuroxime

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Ganga Hospital:

Primary Outcome Measures:
  • Infection percent after surgery [ Time Frame: Within one year after surgery ]

Estimated Enrollment: 1844
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description


Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01372371

Ganga Hospital, Orthopaedics Department Recruiting
Coimbatore, Tamil Nadu, India, 641043
Contact: Janardhan Yerramshetty, Ph.D.    0422-2485000   
Principal Investigator: Rajasekaran Shanmuganathan, Ph.D.         
Sponsors and Collaborators
Ganga Hospital
Principal Investigator: Rajasekaran Shanmuganathan, Ph.D. Ganga Hospital
  More Information

Responsible Party: Dr. S. Rajasekaran, Ph.D., Ganga Hospital Identifier: NCT01372371     History of Changes
Other Study ID Numbers: U1111-1119-9648
Study First Received: June 10, 2011
Last Updated: June 10, 2011

Keywords provided by Ganga Hospital:
Vancomycin, Gentamycin
Local Powder Antibiotic's Efficacy in Controlling Post Surgical Infection

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefuroxime axetil
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017