Efficacy of Local Powder Prophylactics

NCT01372371 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1844

Last updated 2011-06-13

No results posted yet for this study

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.

Conditions

Interventions

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

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.

BIOLOGICAL

Cefuroxime

1 pre-operative dose of Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg)

Sponsors & Collaborators

  • Ganga Hospital

    lead OTHER

Principal Investigators

  • Rajasekaran Shanmuganathan, Ph.D. · Ganga Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372371 on ClinicalTrials.gov