NCT04904653Unknown4 期
Randomized Controlled and Single Blind Clinical Trial in Women With Breast Cancer and Axillary Lymphadenectomy, to Evaluate the Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
Instituto de Investigación Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2021年11月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Total volume in milliliters (ml) of drainage
研究概览
简要总结
Hemopatch is an alternative to reduce morbidity associated with axillary lymphadenectomy surgery, possibly contributing to improved patient management, clinical outcomes, and hospital costs. We propose a multicenter, controlled, and randomized trial to study the efficacy of Hemopatch in reducing serous wound drainage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Preoperative:
- •Female gender
- •Age ≥ 18 years
- •Breast cancer N+
- •Conservative Surgery: Lumpectomy or Quadrantectomy
- •Berg levels 1-2 axillary lymphadenectomy
- •Intraoperative:
- •Axillary incision separated from the incision for the breast lesion
- •Placement of a closed low pressure suction drain in the axillary fossa
- •Hemostasis and lymphostasis using clips, electrocautery, electric scalpel or bipolar coagulation
- •Postoperative:
- •- Patients with ≥ 10 axillary nodes removed
排除标准
- •Preoperative:
- •Mastectomy
- •Previous radiation therapy
- •Previous axillary emptying
- •Liver pathology
- •Diabetic decompensation: defined as any episode that has required medical attention in an emergency service or hospital admission; and also that which has required a modification of the patient's drugs, or an increase of more than 20% of the total daily dose.
- •Known allergies to any component of Hemopatch (proteins of bovine origin or PEG)
- •Psychiatric disorder that conditions the non-understanding of the questionnaire, or incapacitation of the patient to understand it
- •Simultaneous participation in another clinical study
- •PCR positive for SARS-CoV-2
- •Intraoperative:
- •Level 3 axillary dissection (severe axillary involvement)
- •Unexpected surgical contraindication
- •Hemostasis and lymphostasis: ultrasonic techniques or other advanced energy techniques are excluded.
- •Use of fibrin sealants (eg: Tisseel, Artiss, Tachosil), cyanoacrylate type adhesives (eg: Glubran-2) or other types of products (oxidized cellulose format, powders or gelatin sheets or collagen).
研究组 & 干预措施
Hemopatch Group:
Experimental
Hemopatch + suction drainage
干预措施: Hemopatch (Device)
Control group
Other
No sealant (liquid, gel or patch) + suction drain
干预措施: Control group (Other)
结局指标
主要结局
Total volume in milliliters (ml) of drainage
时间窗: In the last 24 hours
Total volume in milliliters (ml) of drainage: To be measured in the hospital every day before discharge, and collected daily after discharge with a follow-up of phone calls or patient diaries during hospital visits until extraction drain.
次要结局
未报告次要终点
研究者
研究点 (1)
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