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临床试验/NCT01899690
NCT01899690撤回4 期

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

Emory University0 个研究点开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
主要终点
Surgical site infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

antibiotic

Experimental

7 days of preventive antibiotics after surgery

干预措施: antibiotic (Drug)

结局指标

主要结局

Surgical site infection

时间窗: one year

Surgical site infection (as defined by CDC consensus guidelines) up to 1 year after implant-based breast reconstruction

次要结局

  • Surgical site infection requiring implant/expander removal(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Grant Carlson

Professor

Emory University

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