Closed Incision Negative Pressure Therapy in Transverse Donor Site Closure of Free Profunda Artery Perforator Flap for Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Re-open
研究概览
简要总结
A retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (PAP) flap by the investigators from January 2015 to August 2021. The included patients will be grouped into two according to the application of incisional negative pressure wound therapy (NP) on the donor site. Patients' demographic data including their age at the surgery, body mass index (BMI), medical comorbidities including the hypertension and diabetes, and smoking history will be obtained from the retrospective chart review. Parameters of the flap will be carefully reviewed, including the flap harvested width, and flap harvested length, the flap harvested and used size, the size of the mastectomy, the ischemia time of the flap. The major interest is in the donor site management and patient's overall recovery. The complications of the donor site will be categorized into acute and chronic ones depending on the time of presence. Donor site complications, such as wound break down, hematoma, seroma, the total amount of the drainage will be recorded. The cutting time point for acute and chronic complications is 1 month. The total amount of drainage from the drainage tube inserted and the patients' off-bed time (day) will also be recorded. Besides, for patients with follow up time of more than 1 year, the scar will be evaluated using Vancouver scar scale.
Statistics Data will be analyzed using graphing and statistical analysis software SPSS 21 software (IBM, Chicago, Illinois, USA). Rank sum and independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant.
Potential risks: No
Confidentiality:
All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients who underwent unilateral microsurgical breast reconstruction using PAP flaps from the PI (JJH) from November 2016 to August 2020
排除标准
- •patients with delayed reconstruction
结局指标
主要结局
Re-open
时间窗: post-operative 14 days
Whether the patient return to the operation room to check the blood flow or re-do the anastomosis.
Off-bed time (days)
时间窗: post-operative 14 days
Vancouver Scar Scale (VSS)
时间窗: 1 year after surgery
Score range from 0-13, used to measure scar the scar appearance. The lower means a better outcome.
Donor site chronic complication (> 30 days)
时间窗: 1 year after surgery
Donor site revision
时间窗: 1 year after surgery
Whether the patient received scar revision surgery on the donor site where the tissue harvested for breast reconstruction.
Drainage amount (ml)
时间窗: post-operative 14 days
Vacuum ball removed timing
时间窗: post-operative 14 days
Donor site acute complication (< 30 days)
时间窗: post-operative 30 days
次要结局
未报告次要终点
研究者
Jung-Ju Huang
Associate Professor
Chang Gung Memorial Hospital
