Experience and Comparison Between Closed Incision Disposable Negative Pressure Wound Therapy With Standard Care in Immediate Postmastectomy Breast Reconstruction - Prospective, Randomized and Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postsurgical complications - reported for 60 patients
研究概览
简要总结
The study aimed to assess the impact of the use of closed incision negative pressure wound therapy (ciNPWT) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic ciNPWT application.
详细描述
Breast cancer excluding skin cancer is the most commonly diagnosed cancer after lung cancer among women. In recent years, the incidence rate of breast cancer has been rising by 0,3% annually. Screening tests are designed to diagnose breast cancer in possible early stadium of disease. Rapid diagnosis and efficacy of neoadjuvant and adjuvant therapies influence on immediate breast reconstructions after skin (SSM) and nipple-sparing mastectomies (NSM). The prophylactic methods of reducing a higher wound healing complication rate after neoadjuvant and adjuvant therapies are crucial.
The study aimed to assess the impact of the use of closed incision negative pressure wound therapy (ciNPWT) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic ciNPWT application.
The analysis included data from anamnesis, details of performed surgical procedure, measurements of skin surface temperature with Skin-Thermometer® probe, measurements of skin elasticity with Cutometer® probe, and scar assessments according to POSAS v2.0 questionnaire for patient and observer.
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
- 否
入选标准
- •>= 18 years of age
- •indications for immediate breast reconstruction
排除标准
- •pregnancy or lactation,
- •use of steroids, use of immune modulators known to affect wound healing;
- •tattoos in the area of the incision;
- •breast skin conditions such as cutis laxa;
结局指标
主要结局
Postsurgical complications - reported for 60 patients
时间窗: 1 year
surgical site complications
次要结局
- Subjective examination of scar quality(1 year after surgery)
- Objective examination of scar quality(1 year after surgery)
- Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast(1 month after surgery)
- Subjective quality of life(1-2 years after surgery)
研究者
Karolina Pieszko
Principal Investigator
University in Zielona Góra