2024-517672-38-00招募中3 期
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)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,003
- 试验地点
- 6
- 主要终点
- All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery
研究概览
简要总结
The BREAST-AB trial is designed to assess the effect of locally applied antibiotics on all-cause loss of the implant after implant-based breast reconstruction. We hypothesise that local application of gentamicin, vancomycin and cefazolin decrease the risk of postoperative clinical infections and thereby reduce the risk of losing the implant to the benefit of women undergoing implant-based breast reconstruction.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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: a. Immediate or delayed reconstructions b. Bilateral or unilateral reconstructions c. With or without simultaneous flap reconstruction
排除标准
- •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
结局指标
主要结局
All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery
All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery
次要结局
- Time to explantation (days)
- All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery (Y/N)
- Revision surgery with incision of the fibrous capsule within 180 days after the breast reconstruction surgery (Y/N)
- Exchange of permanent implant to expander implant within 180 days after the breast reconstruction surgery (Y/N)
- Surgical site infection that leads to antibiotic treatment within 180 days after the breast reconstruction surgery (Y/N)
研究者
Mikkel Herly
Scientific
Rigshospitalet
研究点 (6)
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