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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 24, 2006 | ||||||||
| Last Updated Date | May 21, 2008 | ||||||||
| Start Date ICMJE | October 2003 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Surgical site infection rates in patients with BMI over 25: the risk ratio (RR) contrasting the rate in the prophylaxis group to the rate in the placebo group, and the 95% CIs for the RR. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Surgical site infection rates in patients with BMI over 25: the risk ratio (RR) contrasting the rate in the prophylaxis group to the rate in the placebo group, and the 95% CIs for the RR. | ||||||||
| Change History | Complete list of historical versions of study NCT00356148 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients. | ||||||||
| Official Title ICMJE | Phase IV Study of Determining the Efficacy of Ampicillin/Sulbactam Combination as Antibiotic Prophylaxis During Breast Cancer Surgery in Patients With a BMI Over 25. | ||||||||
| Brief Summary | This is a single center trial to compare the rate of surgical site infection in normal (BMI equal to or less than 25) and overweight (BMI over 25) women who are undergoing breast cancer surgery. The overweight patients are further randomized into two groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam), in the other they do not. |
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| Detailed Description | CONTEXT Although breast surgery is regarded as clean surgery, the actual surgical infection rate is well above accepted range in various series. Retrospective studies showed BMI as one of the factors which may have caused increased SSI rate after breast cancer surgery. Yet, no prospective randomized study assessed the efficacy of chemoprophylaxis during breast surgery in overweight patients. OBJECTIVE To compare the SSI rate between three groups of early stage breast cancer patients in which two are assigned according to randomization. First, patients are grouped into two according to their BMI. All patients (Group I) with BMI equal to or below 25 do not receive any antibiotics as prophylaxis. Patients with a BMI above 25 are randomly assigned to receive a single dose prophylactic ampicillin /sulbactam combination before surgery or not to receive chemoprophylaxis. DESIGN, SETTING AND PATIENTS Patient recruitment is still continuing after the study started in October 2003 in order to reach a sample size of 360 patients with BMI over 25. Advanced or distant metastatic stage, receiving neoadjuvant therapy, history of receiving antibiotics within prior 3 months, history of immunodeficiency, having a remote infection and history of reaction to treatment antibiotics are within the exclusion criteria. INTERVENTIONS All patients are followed for 30 days postoperatively (once in a week at the original surgical unit). Patients and the investigator who inspects all wounds are blinded. The cost of prophylactic antibiotics are compared to the cost of infection treatment (inc. wound care, further antibiotic treatments, hospital visits) in patients who develop SSI. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Breast Cancer | ||||||||
| Intervention ICMJE | Drug: Ampicillin/Sulbactam | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | Cunningham M, Bunn F, Handscomb K. Prophylactic antibiotics to prevent surgical site infection after breast cancer surgery. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005360. Review. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 360 | ||||||||
| Estimated Completion Date | January 2010 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Turkey | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00356148 | ||||||||
| Responsible Party | Bahadir M Gulluoglu, MD, FACS, Marmara University School of Medicine | ||||||||
| Study ID Numbers ICMJE | MAR-YC-2003-0111 | ||||||||
| Study Sponsor ICMJE | Marmara University School of Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Marmara University School of Medicine | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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