Surgical Site Infection and Antibiotic Use Study

Among plastic surgeons, the clinical practice of prescribing postoperative prophylactic antibiotics following postmastectomy breast reconstruction with tissue expanders ranges widely from no postoperative antibiotics, to 5-7 days post-op, to antibiotics until the drains are removed. The Centers for Disease Control and Prevention (CDC) recommends a single preoperative antibiotic dose for clean and clean-contaminated procedures, even in the presence of a drain. With the CDC creating a national action plan to reduce unnecessary prophylactic antibiotics for clean non-contaminated cases by advocating use of only a single pre-operative dose of antibiotics (see: https://www.cdc.gov/drugresistance/pdf/national_action_plan_for_combating_antibotic-resis tant_bacteria.pdf ) there is mounting pressure on the plastic surgery community to adopt this regimen of SSI prophylaxis. Because there are no definitive studies that provide sufficient or conclusive evidence to affect antibiotic practice patterns among plastic surgeons on a large-scale, plastic surgeons use a wide variety of protocols for their SSI prophylaxis, especially in implant-based breast reconstruction. Plastic surgeons have generally not adopted CDC guidelines because these recommendations were not based on studies in plastic surgery patients, and the use of foreign body implants underneath devitalized soft tissue can be associated with higher infection risks. Based on the literature and from self-reporting from ASPS membership, there is a wide range of prophylactic antibiotic use to prevent SSI from as little as one preoperative dose to many weeks of therapy; one week of post-operative antibiotics is the most common form. However, the Centers for Disease Control (CDC) recommends a single preoperative dose of antibiotics for clean cases, even in the presence of a drain. Prolonged antibiotic courses can lead to antibiotic complications and development of resistance.

Definitive studies to determine an optimal therapeutic strategy to prevent SSI in implant-based plastic surgical procedures are lacking. This study will address a dilemma in common plastic surgical operation: the use of post-operative antibiotics in prosthesis-based breast reconstruction.

The central hypothesis for this multi-institutional, prospective randomized control trial (RCT) is that a single pre-operative dose of intravenous antibiotics with intraoperative redosing (SPD) is no worse (noninferiority design) at preventing SSI in tissue expander-based breast reconstruction (TE-BR) than an additional week of post-operative antibiotic prophylaxis (WPO).

This trial will evaluate the efficacy of single preoperative dose versus one-week antibiotic regimens in preventing surgical site infection after tissue expander breast reconstruction. The investigators will assess the rates of SSI from the SPD vs. the WPO groups. They will assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group. The study will also compare the readmission and premature expander removal rates due to SSI and the adverse antibiotic side effects in the two groups.