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Efficacy of Local Powder Prophylactics

This study is currently recruiting participants.
Verified June 2011 by Ganga Hospital
Sponsor:
Information provided by:
Ganga Hospital
ClinicalTrials.gov Identifier:
NCT01372371
First received: June 10, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Ganga Hospital:

Primary Outcome Measures:
  • Infection percent after surgery [ Time Frame: Within one year after surgery ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372371

Locations
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
Principal Investigator: Rajasekaran Shanmuganathan, Ph.D. Ganga Hospital
  More Information

No publications provided

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

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
Cefuroxime axetil
Gentamicins
Vancomycin
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013