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:


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)

  Hide Detailed Description

Detailed Description:
  1. Subjects will be divided into three groups based on the procedure used for the application of antibiotics

    1. No local antibiotics (control group): In this group, individuals will be subjected to peri-operative intravenous* antibiotics only
    2. Gram positive antibiotic: In this group, gram positive (powdered vancomycin)+ will be applied to the site of surgery, before closure of the wound, along with peri-operative intravenous antibiotics*
    3. Gram positive and gram negative: In this group, gram positive (powdered vancomycin) will be instilled on the site of surgery, before closing the wound, and gram negative antibiotic (gentamycin mixed with bone cement)+ will be used, along with peri-operative intravenous antibiotics* (only in cases of implant fixation).

      • Intravenous antibiotic dosage: 1 pre-operative dose of Cefuroxime 1.5 gm and 2 post-operative doses of Cefuroxime 750 mg.

        • Vancomycin and Gentamycin dosage: 500 mg of vancomycin powder will be used and in group 'c' gentamycin mixed with bone cement will be used along with vancomycin powder.
  2. Sample size: Based on, finding at least 4% difference between the proportions of infections found in control (generally 5%, 4% in case of joint replacement) and case groups (1%) (proportions were assumed from literature and our institute records), a sample size of minimum 285 in each group (424 for joint replacement cases) will be considered for the observation to be significant at an alpha level of 0.05. This will give the study a minimum power of 80%.

    Spine cases: Control = 143, Gram-P = 143; Trauma cases: Control = 143, Gram-P = 143; Joint replacement cases: Control = 424, Gram-P = 424, Gram-P+Gram-N = 424; Total = 1844; Where Control - Cases with intravenous antibiotic dose; Gram-P - Cases with intravenous antibiotic + local antibiotic (Vancomycin, acts against gram positive bacteria); Gram-N - Cases with intravenous antibiotic + local antibiotic (Vancomycin, acts against gram positive bacteria) + local Gentamycin cement (acts against gram negative bacteria).

  3. Procedure: Sampling will be based on stratified procedure. The total sample will be divided into categories based on the type of surgery, which are spine, trauma and joint replacement. Subjects within each category will be randomly selected for the three antibiotic treatments. For this study, we will use computer software to generate restricted randomization to achieve balance between groups in size. Within this restricted randomization, single block random size will be used to ensure randomization within each group.

    While joint surgery category will have all the three groups of cases (a, b and c), spine and trauma surgery category will have only two groups (a and b). Surgeries will be performed accordingly i.e. control group individuals will undergo mandated hospital policy requirements + perioperative intravenous antibiotic treatment and cases will undergo mandated hospital policy requirements + powdered vancomycin, or both vancomycin, just before the closure of the wound, and gentamycin as a mix with bone cement. Patients who exhibit both superficial and deep wood infection will be considered as infected and accounted for statistical analysis.

  4. Analysis: Our main parameter of comparison is infection percentage among control and cases. Various factors like duration of surgery, tourniquet time, prior infections, blood transfusion, haemoglobin count, comorbidities, etc, will be considered while analysing for infection percentage. Infection proportions will be compared between different groups at a significance level of 0.05.
  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:
Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
Gentamicins
Vancomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014