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.
