Efficacy of Local Powder Prophylactics
Effects of Applying Powdered Prophylactics Verses Intravenous Antibiotics Only on Post-operative Infection Rate
1 other identifier
interventional
1,844
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 13, 2011
June 1, 2011
1 year
June 10, 2011
June 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection percent after surgery
Within one year after surgery
Study Arms (3)
Vancomycin
ACTIVE COMPARATORVancomycin and Gentamycin
ACTIVE COMPARATORIntravenous Antibiotic
ACTIVE COMPARATORInterventions
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
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.
1 pre-operative dose of Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg)
Eligibility Criteria
You may qualify if:
- All joint replacement patients
- All non infected spine patients
- Hemiarthroplasty, All upper limb plating of closed fractures
You may not qualify if:
- Open injuries in trauma
- Revision joint replacement surgeries
- Patients with suspicion of existing infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ganga Hospitallead
Study Sites (1)
Ganga Hospital, Orthopaedics Department
Coimbatore, Tamil Nadu, 641043, India
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajasekaran Shanmuganathan, Ph.D.
Ganga Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 13, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2013
Last Updated
June 13, 2011
Record last verified: 2011-06