Reduction of Seroma and Improvement of Quality of Life After Early Drain Removal in Immediate Breast Reconstruction With Tissue Expander. Preliminary Report of a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 主要终点
- days with drainage
研究概览
简要总结
The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving clinical outcomes and quality of life (QoL). The mechanism of action underlying the proposed approach was intuitive. The early drain removal allows to: 1) avoid continuous seroma development caused by active suction of drain (stopping the circle "drain itself may perpetuate the drainage" with vacuum mechanism); 2) reduce the risks connected to "foreign body reaction" as tissue inflammation and infection; 3) improve QoL reducing pain, length of hospital stay and limitations of daily activities.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •SNS (skin nipple sparing) or SS (skin sparing) mastectomy for breast cancer and immediate positioning of breast expander (without mesh) with placement of suction drain, regardless of TNM classification
排除标准
- •skin reducing mastectomy, reconstruction with flap, direct to implant reconstruction (with or without mesh or ADM) and axillary dissection
结局指标
主要结局
days with drainage
时间窗: 21 days
time until wound healing (days)
时间窗: 21 days
infection (yes or not)
时间窗: 21 days
defined as the appearance of local signs/symptoms as erythema, edema, induration, increased pain, and a change in drainage to a purulent nature and fever, confirmed by swabs
complicated wound healing (yes or not)
时间窗: 21 days
unclosed wound 3 weeks postoperatively
days of seroma formation
时间窗: 21 days
period that drain or seroma aspiration is needed in days after surgery
total fluid volume (ml)
时间窗: 21 days
sum of drain volumes and volume of seroma aspirations if needed
次要结局
- pain (using Visual Analogic Score scale to measure intensity)(21 days)
- disturbance in quality of sleep (yes or not)(21 days)
- disturbance in mobility (yes or not)(21 days)
- limitation in personal care, daily activities and social life (yes or not)(21 days)
研究者
Lembo Fedele
Principal Investigator
University of Foggia