Antibiotics and Tissue Expanders in Breast Reconstruction
Primary Purpose
Complications; Breast Prosthesis, Infection or Inflammation
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
antibiotic
Sponsored by
About this trial
This is an interventional prevention trial for Complications; Breast Prosthesis, Infection or Inflammation focused on measuring breast reconstruction, cancer, expander, antibiotics, infection, surgical site infection, surgery, oncology, plastic surgery
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
antibiotic
No antibiotic
Arm Description
7 days of preventive antibiotics after surgery
No preventive postoperative antibiotics
Outcomes
Primary Outcome Measures
Surgical site infection
Surgical site infection (as defined by CDC consensus guidelines) up to 1 year after implant-based breast reconstruction
Secondary Outcome Measures
Surgical site infection requiring implant/expander removal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01899690
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The study was withdrawn prior to IRB approval.
Study Start Date
June 2016 (Anticipated)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Breast Prosthesis, Infection or Inflammation
Keywords
breast reconstruction, cancer, expander, antibiotics, infection, surgical site infection, surgery, oncology, plastic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
antibiotic
Arm Type
Experimental
Arm Description
7 days of preventive antibiotics after surgery
Arm Title
No antibiotic
Arm Type
No Intervention
Arm Description
No preventive postoperative antibiotics
Intervention Type
Drug
Intervention Name(s)
antibiotic
Other Intervention Name(s)
cephalexin (Keflex), clindamycin, bactrim, (in order of choice pending relevant allergies)
Intervention Description
Patients after breast reconstruction with implant/tissue expander reconstruction who receive the intervention will be prescribed with a 7 day course of postoperative antibiotics.
Primary Outcome Measure Information:
Title
Surgical site infection
Description
Surgical site infection (as defined by CDC consensus guidelines) up to 1 year after implant-based breast reconstruction
Time Frame
one year
Secondary Outcome Measure Information:
Title
Surgical site infection requiring implant/expander removal
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant W Carlson, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Antibiotics and Tissue Expanders in Breast Reconstruction
We'll reach out to this number within 24 hrs