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The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing breast reconstruction who have drains placed for several days after surgery is controversial. In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains. Patients will sign an informed consent form prior to the surgery and will be randomized to one of the antibiotic regimens. Patients will be closely followed up to one year after surgery. The number of surgical site infections according to the NNIS criteria and loss of breast implants will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short antibiotic course | Active Comparator | Intravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery |
|
| Prolonged antobiotic treatment | Experimental | Intravenous 2 gram cefazolin every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged antibiotic treatment | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| surgical site infection | The percentage and number of surgical site infections assessed according to the NNIS criteria up to one year after reconstructive breast surgery will be compared between the two groups | 1 year |
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Inclusion Criteria:
All criteria should be present:
Exclusion Criteria:
Age < 18 years Active infection at the surgical site at the operation time or in close proximity to the surgical site Immune deficiency state
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmin Maor, MD | Contact | yasmin.maor@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Yasmin Maor, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of plastic surgery, Sheba medical center | Tel Litwinsky | 52621 | Israel |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Short antibiotic course (standard of care) | Drug |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |