InfectionNCT01372371
Efficacy of Local Powder Prophylactics
A study testing Vancomycin, Vancomycin and Gentamycin and Cefuroxime in people with Infection, run by Ganga Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Vancomycin, Vancomycin and Gentamycin and Cefuroxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,844 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All joint replacement patients
- All non infected spine patients
- Hemiarthroplasty, All upper limb plating of closed fractures
Who cannot join
- Open injuries in trauma
- Revision joint replacement surgeries
- Patients with suspicion of existing infection
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Ganga Hospital, Orthopaedics Department
Coimbatore, Tamil Nadu, 641043
Janardhan Yerramshetty, Ph.D., 0422-2485000, jyerram@gmail.com
Rajasekaran Shanmuganathan, Ph.D.
About this study
Official title: Effects of Applying Powdered Prophylactics Verses Intravenous Antibiotics Only on Post-operative Infection Rate
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.
Read the detailed description
- Subjects will be divided into three groups based on the procedure used for the application of antibiotics
- No local antibiotics (control group): In this group, individuals will be subjected to peri-operative intravenous* antibiotics only
- 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*
- 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.
- 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).
- 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.
- 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.
- Conditions
- Infection
- Being tested
- Vancomycin, Vancomycin and Gentamycin, Cefuroxime
- Keywords
- Vancomycin, Gentamycin, Local Powder Antibiotic's Efficacy in Controlling Post Surgical Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinBiological
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
Vancomycin and GentamycinBiological
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.
CefuroximeBiological
1 pre-operative dose of Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg)
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Active comparator | Not described Receives: Biological: Vancomycin |
| Vancomycin and Gentamycin | Active comparator | Not described Receives: Biological: Vancomycin and Gentamycin |
| Intravenous Antibiotic | Active comparator | Not described Receives: Biological: Cefuroxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection percent after surgery
Measured: Within one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,844 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganga Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Rajasekaran Shanmuganathan, Ph.D., Principal investigator, Ganga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372371
- Sponsor's protocol ID
- U1111-1119-9648
- Status last verified
- Jun 2011
- First submitted
- 10 Jun 2011
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Applying Powdered Prophylactics Verses Intravenous Antibiotics Only on Post-operative Infection Rate
- ClinicalTrials.gov ID
- NCT01372371
- Acronym / sponsor ID
- U1111-1119-9648
- Conditions
- Infection
- Keywords
- Vancomycin, Gentamycin, Local Powder Antibiotic's Efficacy in Controlling Post Surgical Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,844 participants (estimated)
- Lead sponsor
- Ganga HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Subjects will be divided into three groups based on the procedure used for the application of antibiotics
- No local antibiotics (control group): In this group, individuals will be subjected to peri-operative intravenous* antibiotics only
- 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*
- 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.
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Active comparator | Biological: Vancomycin |
| Vancomycin and Gentamycin | Active comparator | Biological: Vancomycin and Gentamycin |
| Intravenous Antibiotic | Active comparator | Biological: Cefuroxime |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All joint replacement patients
- All non infected spine patients
- Hemiarthroplasty, All upper limb plating of closed fractures
Key exclusion criteria (3 listed)
- Open injuries in trauma
- Revision joint replacement surgeries
- Patients with suspicion of existing infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin1 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 |
| Vancomycin and Gentamycin1 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 | Vancomycin and Gentamycin |
| Cefuroxime1 pre-operative dose of Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg) | Biological | Intravenous Antibiotic |
Primary outcome
Infection percent after surgery
Time frame: Within one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajasekaran Shanmuganathan, Ph.D. principal investigator
Ganga Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycin, Vancomycin and Gentamycin and Cefuroxime in people with Infection, run by Ganga Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection percent after surgery (time frame: Within one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2011.