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
Recruitment status was Recruiting
Sponsor:
Ganga Hospital
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
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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)
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 10 Years and older (Child, Adult, Senior) |
| 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
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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
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
| 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:
|
Infection Anti-Bacterial Agents Vancomycin Gentamicins Cefuroxime Cefuroxime axetil |
Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 27, 2016