Efficacy of Local Powder Prophylactics

Infection Clinical Trial

Official title:

Effects of Applying Powdered Prophylactics Verses Intravenous Antibiotics Only on Post-operative Infection Rate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01372371
• Other study ID #: U1111-1119-9648
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2011
• Last updated: June 10, 2011
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2011
• Source: Ganga Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical 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. The investigators also think powders that control both gram positive and gram negative bacteria are more beneficial.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1844
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

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
• 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.
• Cefuroxime
1 pre-operative dose of Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg)

Locations

Country	Name	City	State
India	Ganga Hospital, Orthopaedics Department	Coimbatore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Ganga Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection percent after surgery		Within one year after surgery	Yes