Prospective Clinical Investigation for a Randomized, Controlled, Multicenter Non-inferiority Study Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 10
- 主要终点
- Number of Post-Operative Clinical Interventions
研究概览
简要总结
Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy
详细描述
A prospective, randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy. Patients will be enrolled for 90 Days from day of Surgery. It is expected that it will take 6-9 months for the full duration of the study including the 90 day follow up period.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age;
- •Provide signed and dated informed consent form;
- •Willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study;
- •Willing to follow instructions for incision care and follow guidelines related to resumption of daily activities;
- •Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in this study is complete;
- •In good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history, and review of recent concomitant medications;
- •Requiring a mastectomy (standard, modified, modified radical) with or without sentinel node biopsy;
- •≤ ASA 3 - American Society of Anesthesiologists Physical Classification System
排除标准
- •Pregnancy or lactation;
- •Known medical condition that results in compromised blood supply to tissues;
- •Known or suspected allergy or sensitivity to any test materials or reagents;
- •Any condition known to affect wound healing, such as collagen vascular disease;
- •Receiving antibiotic therapy for pre-existing condition or infection;
- •Planned immediate breast reconstruction;
- •Concurrent use of fibrin sealants or other internal wound care devices;
- •Unable to understand questions, instructions or the informed consent presentation in the language of the investigators performing the study;
- •Requiring a mastectomy with ALND (as determined at time of surgery);
- •Be participating in any conflicting medical device clinical trial within 30 days of enrollment in this study.
研究组 & 干预措施
Test - Standard Closure with TissuGlu Surgical Adhesive
Standard closure plus treatment with TissuGlu
干预措施: Test - Standard Closure with TissuGlu Surgical Adhesive (Device)
Control - Standard Closure
Standard closure with no intervention
结局指标
主要结局
Number of Post-Operative Clinical Interventions
时间窗: from day 0 to day 90
Clinical Intervention is defined as one of the following events: 1. Removal of an in-dwelling drain (As defined in the Protocol); 2. Needle aspiration to remove fluid from a Clinically-Relevant Seroma (As defined in the Protocol); 3. Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures; 4. Reinsertion or insertion of a drain post operatively; 5. Surgical procedures due to wound healing complications related to wound management
次要结局
- Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)(Day 1, 5, 14, 30, 90)
- Days to drain removal(Day 1, 5, 14, 30, 90)
- Number of Clinically Relevant Seromas formation (number and aspiration volume)(Day 1, 5, 14, 30, 90)
- Incidence and timing of initiation of adjuvant therapy related to the mastectomy procedure (such as radiation therapy, chemotherapy, endocrine therapy)(Day 1, 5, 14, 30, 90)
- Days to discharge from hospital(Day 1, 5, 14, 30, 90)
- Wound healing related complications(Day 1, 5, 14, 30, 90)
- Patient Benefit Questionnaire(Day 1, 5, 14, 30, 90)
- Cumulative days of treatment (with drains or aspiration)(Day 1, 5, 14, 30, 90)