Efficacy of Local Powder Prophylactics

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2011 by Ganga Hospital.
Recruitment status was Recruiting

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

Drug Information available for: Gentamicin Vancomycin Vancomycin hydrochloride Gentamicin sulfate Cefuroxime Cefuroxime sodium Cefuroxime axetil

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)

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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

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 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:


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

ClinicalTrials.gov processed this record on March 03, 2015

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