Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive
2020年11月20日 更新者：Case Comprehensive Cancer Center
Drain-Less Abdominally Based Breast Reconstruction Using a Novel Lysine-Derived Urethane Adhesive (TissueGlu, Cohera Medical)
Drains are routinely utilized in breast reconstruction when using abdominal tissue of the patient to remove fluid buildup while the body heals after surgery. However, drains are associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and outpatient visits. Drains can also serve as a site of origin for infection as the system is not completely closed, and infectious organisms could theoretically use the drain as point of entry.
This proposed study investigates a potential novel mechanism to prevent the development of seromas (pockets of clear fluid which can develop after surgery) in patients who undergo breast reconstruction with their own abdominal tissue. By eliminating the required use of a drain, the study team expects patients to have less pain and use less pain medication, as well as more satisfaction with their overall surgical experience.
研究概览
详细说明
Objectives:
- Establish the safety of a lysine-derived urethane adhesive (TissuGlu, Cohera Medical) in patients undergoing autologous abdominal-based breast reconstruction. This will be assessed via analyzing complication profiles of patients post-operatively. The primary endpoints are rate of seroma development, need for seroma drainage and time to drain removal (if in drain group).
- Determine if there is a difference in pain and other quality of life measures when comparing patients who do and do not have abdominal drains. This will be assessed via pain medicine utilization and by delivering a targeted survey pre-operatively, as well as at post-operative day three and four weeks.
Study Design:
Patients will be randomized to one of three arms: 1) Traditional closed-suction drains, 2) TissuGlu with closed-suction drains and 3) TissuGlu without closed-suction drains.
研究类型
介入性
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
22年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Patients undergoing Abdominally-Based Breast Reconstruction
- Both unilateral or bilateral reconstruction is allowed
- Both delayed or immediate reconstruction is allowed
Exclusion Criteria:
- Diabetes
- BMI>30
- Active smokers.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Tissue Glu with drains
This is standard of care to use Tissue Glu in addition to a drain.
Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities.
Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
|
Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied.
Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
其他名称：
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
其他名称：
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
|
|
实验性的：Tissue Glu without drains
This group utilizes Tissue Glu without the presence of a drain.
Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities.
Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
|
Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied.
Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
其他名称：
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
|
|
有源比较器：Drains
This is standard of care to use traditional closed-suction drains.
Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities.
Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
|
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
其他名称：
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of seroma development
大体时间：Up to 30 days after surgery
|
Number of seromas which develop during the first 30 days after surgery.
|
Up to 30 days after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in pain between patients with and without abdominal drains
大体时间：Up to 4 weeks after surgery
|
Patients will be given a questionnaire pre-operatively and the same questionnaire post-operatively.
The change in these questionnaires will be compared between groups
|
Up to 4 weeks after surgery
|
|
Pain Medicine Utilization
大体时间：Up to 4 weeks after surgery
|
Use of pain medicine after surgery between groups, as indicated by chart review
|
Up to 4 weeks after surgery
|
|
Time to drain removal
大体时间：Up to 4 weeks after surgery
|
Time from surgery to the removal of the drain for any reason, in patients who were given a drain
|
Up to 4 weeks after surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Andrea Moreira, MD、Cleveland Clinic, Case Comprehensive Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年11月1日
初级完成 (预期的)
2021年2月1日
研究完成 (预期的)
2021年9月1日
研究注册日期
首次提交
2017年5月17日
首先提交符合 QC 标准的
2017年5月17日
首次发布 (实际的)
2017年5月18日
研究记录更新
最后更新发布 (实际的)
2020年11月24日
上次提交的符合 QC 标准的更新
2020年11月20日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Tissue Glu的临床试验
-
M3 HealthIrmandade da Santa Casa de Misericordia de Sao Paulo尚未招聘
-
Jonsson Comprehensive Cancer Center主动，不招人
-
City of Hope Medical CenterNational Cancer Institute (NCI)完全的
-
Jonsson Comprehensive Cancer Center完全的