Interest of Local Compression by Thoracic Bandage on the Management of Seroma in Patients Treated by Mastectomy With or Without Lymphadenectomy. Local Compression Seroma DIminution Objective
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of puncture(s) after inclusion in both patient groups
研究概览
简要总结
This study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. Half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.
详细描述
The most common complication induced by mastectomy is seroma formation. This seroma is a serolymphatic effusion that is created in the days following surgery. Iterative puncture is the only treatment for seroma mentioned in the literature. A retrospective study in the investigator's establishment on 1800 patients determined that a second puncture greater than 250ml is predictive of a chronicisation of punctures. The research hypothesis is that by applying local compression by chest bandaging with the Urgo® K2 kit, the "dead space" created by surgery would be removed. This would help resorb the seroma and reduce the number of punctures.
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
- •Patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing.
- •Patient with a second seroma puncture with a volume greater than or equal to 250 ml.
- •Neo adjuvant chemotherapy authorized.
- •Absence of known metastases.
- •Patient has given written consent.
排除标准
- •Mastectomy with immediate reconstruction.
- •Partial mastectomy.
- •Concurrent bilateral mastectomy.
- •Delay in healing observed at inclusion.
- •Patient under legal protection.
- •Chronic respiratory failure.
- •Patient with a pacemaker.
- •Personality disorders and known progressive psychiatric pathology.
- •Inability to submit to trial follow-up
研究组 & 干预措施
punctures
After the second puncture, the patient will be seen at the same frequency as in the experimental arm.
The decision to perform a puncture will be made according to the same criteria and the follow-up conditions will be identical.
干预措施: punctures (Procedure)
Compression by chest bandage urgo K2®
After the second puncture, the local compression by thoracic bandage will be put in place.
The system being effective 7 days, it will be left in place between each visit. A visit will be made for all patients 7 days after the installation of the device. However, if necessary, an intermediate visit may be carried out.
During these visits, a puncture will be made according to the criteria mentioned above. The bandage will be renewed after each visit.
The device will be removed after 15 days without indication of a new puncture. The patient will be seen again between 10 and 15 days after the bandage is removed for a final evaluation.
干预措施: Compression by chest bandage urgo K2® (Device)
Compression by chest bandage urgo K2®
After the second puncture, the local compression by thoracic bandage will be put in place.
The system being effective 7 days, it will be left in place between each visit. A visit will be made for all patients 7 days after the installation of the device. However, if necessary, an intermediate visit may be carried out.
During these visits, a puncture will be made according to the criteria mentioned above. The bandage will be renewed after each visit.
The device will be removed after 15 days without indication of a new puncture. The patient will be seen again between 10 and 15 days after the bandage is removed for a final evaluation.
干预措施: punctures (Procedure)
结局指标
主要结局
Number of puncture(s) after inclusion in both patient groups
时间窗: 180 days
In each group, we will count the number of punctures performed after the 2nd puncture with a volume \> 250ml (inclusion).
次要结局
- The time required to take charge of adjuvant treatments(180 days)
- comparison of the average change Quality of life scores between each arm(180 days)
- comparison of the average change Pain scores between each arm(180 days)
- comparison of the average change anxiety scores between each arm(180 days)
- Volume punctured after inclusion in both patient groups.(180 days)
- The aesthetic impact on the puncture site.(180 days)
- Validation of a score allowing the description of the seroma of grades 2 and the indication of a puncture(180 days)