A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 392
- 试验地点
- 14
- 主要终点
- Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads)
研究概览
简要总结
The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue expanders placed during mastectomy. The researchers will also study whether Stimulan Rapid Cure affects the risk of seroma, a possible complication of surgery that involves fluid buildup under the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Female sex
- •Aged 18 years or older
- •Planned to undergo mastectomy for breast cancer, genetic predisposition to and/or strong family history of breast cancer, or other prophylactic indication
- •Planned to undergo unilateral or bilateral immediate breast reconstruction (i.e., reconstruction at the time of mastectomy) with prepectoral TE placement at MSK
- •BMI less than 40 kg/m2
- •Not actively smoking or using other nicotine products within 6 weeks of surgery
- •No contraindications to Stimulan antibiotic bead placement: hypercalcemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, and severe degenerative bone disease
- •No known allergy to calcium sulfate, vancomycin, or gentamicin
- •No impaired decision-making capacity
排除标准
- 未提供
研究组 & 干预措施
Patients randomized to Tissue Expander (TE) + antibiotic beads
干预措施: Tissue Expander (TE) (Procedure)
Patients randomized to Tissue Expander (TE) + antibiotic beads
干预措施: Stimulan Rapid Cure (Device)
Patients randomized to Tissue Expander (TE) only
干预措施: Tissue Expander (TE) (Procedure)
Patients randomized to Tissue Expander (TE) + antibiotic beads
干预措施: Vancomycin and Gentamicin (Drug)
结局指标
主要结局
Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads)
时间窗: within 90 days postoperatively
The researchers define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology \[seroma, radiation\]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively
Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only)
时间窗: within 90 days postoperatively
The researchers define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology \[seroma, radiation\]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively
Surgical site infections (SSI) incidence
时间窗: within 90 days postoperatively
We will define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology \[seroma, radiation\]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively
次要结局
- Compare the rates of seroma (cohort PatientsTissue Expander (TE) + antibiotic beads)(within 90 days postoperatively)
- Compare the rates of seroma (cohort Patients randomized to Tissue Expander (TE) only)(within 90 days postoperatively)
- Compare the rates of seroma(within 90 days postoperatively)