Surgical Site Infection and Antibiotic Use Study

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients will be randomly assigned to one of the two treatment groups. One group will receive a single dose of antibiotics just before surgery and if necessary, more doses during the surgery. The other group will receive the same treatment as the first group, along with an additional week of antibiotics after surgery. The study will assess the rates of SSI from the two groups. It will also assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Plastic Surgery Foundation
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

• Women 18 years or older, undergoing unilateral or bilateral mastectomy (including breast cancer, any stage, or prophylactic) and immediate tissue expander reconstruction (including submuscular, submuscular and ADM, or pre-pectoral placement).

Exclusion Criteria:

• Breast cancer patients not undergoing mastectomy

• Patients undergoing direct-to-implant reconstruction

• Patients undergoing delayed reconstruction

• Patients having autologous reconstruction

• History of radiation to the breast or chest

• History of previous breast reconstruction on the side of expander placement

• Patients with serious existing systemic infection, defined as 2 or more of the following: Peripheral body temperature >38 degrees Celsius CRP >5g/L Leukocytes > 12,000/microliter at the time of enrollment.