Efficacy of Local Powder Prophylactics
Information source: Ganga Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection
Intervention: Vancomycin (Biological); Vancomycin and Gentamycin (Biological); Cefuroxime (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: Ganga Hospital Official(s) and/or principal investigator(s): Rajasekaran Shanmuganathan, Ph.D., Principal Investigator, Affiliation: Ganga Hospital
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.
Clinical Details
Official title: Effects of Applying Powdered Prophylactics Verses Intravenous Antibiotics Only on Post-operative Infection Rate
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Infection percent after surgery
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
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ganga Hospital, Orthopaedics Department, Coimbatore, Tamil Nadu 641043, India; Recruiting Janardhan Yerramshetty, Ph.D., Phone: 0422-2485000, Email: jyerram@gmail.com Rajasekaran Shanmuganathan, Ph.D., Principal Investigator
Additional Information
Starting date: June 2011
Last updated: June 10, 2011
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