Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,003
- 试验地点
- 8
- 主要终点
- All-cause explantation of the breast implant after the breast reconstruction surgery
研究概览
简要总结
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.
详细描述
The BREAST-AB Trial will include women undergoing breast reconstruction with implants. The objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. Participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. All patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. All patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. A total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial will be double-blind so that the patients, site investigators and data monitors will be blinded to the allocation. Only the designated nurses and the members of the trial coordinating unit (who provide the randomization number and treatment allocation) are not blinded to the allocation. The unblinded persons will not in any way be part of the treatment, clinical evaluation of outcomes or data assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Biologically female
- •Signed informed consent
- •Scheduled for breast reconstruction with implants or expanders including:
- •Immediate or delayed reconstructions
- •Bilateral or unilateral reconstructions
- •With or without simultaneous flap reconstruction
排除标准
- •Pregnancy
- •Breast feeding
- •Known allergy towards Vancomycin, Gentamicin and Cefazolin
- •Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
- •Known allergy towards neomycin
- •Known impaired renal function with GFR < 60 mL/min
- •Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
- •Myasthenia Gravis
研究组 & 干预措施
Irrigation of implants with sterile isotonic saline
The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.
干预措施: Placebo (Other)
Irrigation of implants with a triple antibiotic solution
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline
干预措施: Gentamicin, Cefazolin and Vancomycin (Drug)
结局指标
主要结局
All-cause explantation of the breast implant after the breast reconstruction surgery
时间窗: 180 days
All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation.
次要结局
- Time to explantation (days)(180 days)
- Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery(180 days)
- All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery(1 year)
- Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)(180 days)
- Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)(180 days)
研究者
Mikkel Herly
MD, Ph.d.
Rigshospitalet, Denmark