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临床试验/NCT05491473
NCT05491473已完成不适用

Closed Incision Negative Pressure Therapy in Transverse Donor Site Closure of Free Profunda Artery Perforator Flap for Breast Reconstruction

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年9月23日最近更新:
适应症

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

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

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung-Ju Huang

Associate Professor

Chang Gung Memorial Hospital

研究点 (1)

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