Breast Cancer
Conditions
Keywords
breast cancer, breast surgery, clean wound, overweight, prophylaxis, antibiotics
Brief summary
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).
Detailed description
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.
Interventions
Ampicillin/Sulbactam 1 gr, once within onr hour before surgery
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.
Exclusion criteria
* Ductal carcinoma in situ (DCIS; stage 0 cancer), * Advanced or distant metastatic stage, * Receiving any neoadjuvant therapy, * History of receiving any antibiotics within prior 3 months, * History of immunodeficiency, * Having a remote infection, * History of reaction to study antibiotics, * Denial of signing the consent form.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Patients were recruited at a tertiary university teaching hospital between October 2003 and March 2010.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Prophylaxis Group patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis | 189 |
| No Prophylaxis Group Patients who are BMI over 25 and do not receive antibiotic prophylaxis | 183 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Reoperation within 30 days | 2 | 1 |
Baseline characteristics
| Characteristic | Prophylaxis Group | No Prophylaxis Group | Total |
|---|---|---|---|
| Age Continuous | 59.1 years STANDARD_DEVIATION 11.1 | 56.9 years STANDARD_DEVIATION 14.1 | 57.5 years STANDARD_DEVIATION 13.3 |
| Sex: Female, Male Female | 189 Participants | 183 Participants | 372 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 189 | 0 / 183 |
| serious Total, serious adverse events | 0 / 189 | 0 / 183 |
Outcome results
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).
Time frame: 1 month
Population: Analysis was intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prophylaxis Group | 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). | 9 participants |
| No Prophylaxis Group | 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). | 25 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).
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prophylaxis Group | Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group). | 30 Monetary unit in Turkish Liras | Standard Error 5.6 |
| No Prophylaxis Group | Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group). | 13 Monetary unit in Turkish Liras | Standard Error 3.2 |