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This is a single center trial to compare the rate of surgical site infection (SSI) in normal (BMI equal to or less than 25; Control Group)) 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; Prophylaxis Group), in the other they do not (No Prophylaxis Group).
CONTEXT Although breast surgery is regarded as clean surgery, the actual SSI 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 (Control Group) 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 (Prophylaxis Group) or not to receive chemoprophylaxis (No Prophylaxis Group).
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. Cost of SSI-related prophylaxis and treatments (including additional hospital visits after discharge, physician charges, additional antibiotics, wound management, other drugs and interventions etc) is calculated in each study group and compared with each other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylaxis Group | Active Comparator | patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis |
|
| No Prophylaxis Group | No Intervention | Patients who are BMI over 25 and do not receive antibiotic prophylaxis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampicillin/Sulbactam | Drug | Ampicillin/Sulbactam 1 gr, once within onr hour before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group). | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bahadir M Gulluoglu, MD, FACS | Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University Hospital | Istanbul | 34662 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16625637 | Background | 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. doi: 10.1002/14651858.CD005360.pub2. | |
| 23001082 | Derived | Gulluoglu BM, Guler SA, Ugurlu MU, Culha G. Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: a randomized controlled trial. Ann Surg. 2013 Jan;257(1):37-43. doi: 10.1097/SLA.0b013e31826d832d. |
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Patients having male gender, diagnosis of Stage 0, locally advanced or bilateral breast cancer, receiving neoadjuvant treatment, planning to undergo reconstructive surgery, having immunodeficiency, receiving antibiotics during previous one month, undergoing breast / axilla operation before randomization, denying to provide consent were excluded.
Patients were recruited at a tertiary university teaching hospital between October 2003 and March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prophylaxis Group | patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis |
| FG001 | No Prophylaxis Group | Patients who are BMI over 25 and do not receive antibiotic prophylaxis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prophylaxis Group | patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis |
| BG001 | No Prophylaxis Group | Patients who are BMI over 25 and do not receive antibiotic prophylaxis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group). | Analysis was intent-to-treat | Posted | Number | participants | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prophylaxis Group | patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Bahadir M Gulluoglu | Marmara University School of Medicine | 902164256565 | 4012 | bmgulluoglu@marmara.edu.tr |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C035444 | sultamicillin |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group). | Posted | Mean | Standard Error | Monetary unit in Turkish Liras | 1 month |
|
|
|
| 0 |
| 189 |
| 0 |
| 189 |
| EG001 | No Prophylaxis Group | Patients who are BMI over 25 and do not receive antibiotic prophylaxis | 0 | 183 | 0 | 183 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |