Antibiotics and Tissue Expanders in Breast Reconstruction

Sponsor

Emory University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01899690

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Complications; Breast Prosthesis, Infection or Inflammation	Drug: antibiotic	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Impact of Prophylactic Perioperative Antibiotic Administration on Surgical Site Infections Following Implant-based Breast Reconstruction.

Anticipated Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: antibiotic 7 days of preventive antibiotics after surgery	Drug: antibiotic Patients after breast reconstruction with implant/tissue expander reconstruction who receive the intervention will be prescribed with a 7 day course of postoperative antibiotics. Other Names: cephalexin (Keflex) clindamycin bactrim (in order of choice pending relevant allergies)
No Intervention: No antibiotic No preventive postoperative antibiotics

Arm

Intervention/Treatment

Experimental: antibiotic

7 days of preventive antibiotics after surgery

Drug: antibiotic

Patients after breast reconstruction with implant/tissue expander reconstruction who receive the intervention will be prescribed with a 7 day course of postoperative antibiotics.

Other Names:

cephalexin (Keflex)

clindamycin

bactrim

(in order of choice pending relevant allergies)

No Intervention: No antibiotic

No preventive postoperative antibiotics

Outcome Measures

Primary Outcome Measures

Surgical site infection [one year]
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 [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.