Clinical trial NCT01899690: Antibiotics and Tissue Expanders in Breast Reconstruction
Official title: Impact of Prophylactic Perioperative Antibiotic Administration on Surgical Site Infections Following Implant-based Breast Reconstruction.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Complications; Breast Prosthesis, Infection or Inflammation
Keywords: breast reconstruction
cancer
expander
antibiotics
infection
surgical site infection
surgery
oncology
plastic surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction. The investigators hypothesize that use of prophylactic antibiotics after breast reconstruction does not reduce surgical site infections.

Detailed description: Surgical site infections occur in up to one-third of patients who undergo implant-based breast reconstruction following mastectomy for cancer; most of such cases require subsequent prosthetic removal. This elevated risk relative to other surgical procedures and patient populations has been attributed to cancer-related immunocompromise, foreign body placement, postoperative drainage tube maintenance, and chemoradiotherapy administration. The use of extended postoperative prophylactic antibiotics is prevalent amongst plastic surgeons despite lack of evidence supporting efficacy of such practice. Further, the National Surgical Care Initiative Project (SCIP) as sponsored by the Centers for Medicare \& Medicaid Services (CMS) mandates discontinuation of antibiotics by 24 hours after surgery, as further extension not only fails to reduce infection risk in the general surgical population, but also may contribute to bacterial resistance. The primary objective of this study is to compare the risk of surgical site infection in implant-reconstruction patients who receive extended prophylactic antibiotics with those who do not. In this randomized-controlled trial, women at a single institution who undergo implant-based breast reconstruction will be assigned to receive either less than 24 hours or 7 days of prophylactic postoperative antibiotics. Primary outcome measures will include development of superficial incisional, deep incisional, and organ/space surgical site infections at one year as defined by the Centers for Disease Control (CDC). Following adjustment for patient age, body mass index, comorbid disease, reconstructive timing, disease stage, adjuvant therapy, implant volume, drain use, and other procedural variables, relative risk of postoperative infection with use of extended prophylactic antibiotics will be estimated. Secondary outcome measures will include prosthetic explantation and, in cases of infection, bacteriology and antibiotic susceptibilities.

Eligibility criteria: Inclusion Criteria:

* Patients in whom implant-based breast reconstruction is selected based on clinician recommendation, patient agreement, and mutual consensus.
* Ability to understand the purposes and risks of the study and willingly give standard written informed consent for treatment established by Emory University Hospital and affiliates.

Exclusion Criteria:

* Pregnancy
* Incarceration
* Non-implant based reconstructive plan
* Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.

Primary outcomes:
measure: Surgical site infection
timeFrame: one year
Secondary outcomes:
measure: Surgical site infection requiring implant/expander removal
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Grant W Carlson, MD
role: PRINCIPAL_INVESTIGATOR
References: