Clinical trial NCT04631185: Surgical Site Infection and Antibiotic Use Study
Official title: Antibiotics and Surgical Site Infection in Expander Based Breast Reconstruction Trial (ASSERT) A Multi-institutional Randomized Controlled Trial to Determine the Optimal Antibiotic Prophylaxis for Tissue Expander-based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Breast Reconstruction
Antibiotic Use
Lead sponsor: The Plastic Surgery Foundation
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 235
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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-resistant_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.

Eligibility 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.

Primary outcomes:
measure: Number of participants in each group who develop surgical site infection (SSI) within 30 days of index procedure.
timeFrame: Up to 30 days after the index procedure
Secondary outcomes:
measure: Number of participants in each group with antibiotic-related adverse events and the type of adverse events reported.
timeFrame: Up to 30 days after the index procedure
measure: Number of participants in each group who develop an SSI or other complications after 30 days of index procedure.
timeFrame: Up to two years
measure: Number of participants in each group who undergo premature tissue expander or implant removal.
timeFrame: From index procedure until expander removal
measure: Type, duration and route of antibiotic administration (Oral or Intravenous) in participants in each group who develop SSI/deep infections.
timeFrame: Up to two Years
measure: Comparison of any secondary infections, including resistant bacterial strains and yeast infections, in participants from the two groups who develop SSI.
timeFrame: Up to two Years
measure: ER visit and hospital readmission rates among participants in both groups.
timeFrame: Up to two Years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Columbia University
name: Christine Rohde, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Brian Gastman, MD
role: PRINCIPAL_INVESTIGATOR
References: