此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Buccal Mucosa Healing Trial With Tissue Matrix Placement

2019年6月3日 更新者:NYU Langone Health

A Prospective Randomized Controlled Trial of Buccal Mucosa Donor Site Healing With Tissue Matrix Placement

Prior studies have been performed to understand the optimal way to minimize the morbidity rate of buccal mucosa. While some studies have reported primary closure to be inferior to healing by secondary intention, this appears to be true for large defects greater than 2 cm in width. For small defects for which the wound can be closed without tension, the most recent study has shown improved pain outcomes in the immediate post-operative setting, although no difference is seen long term whether or not the wound was primarily closed. However, for larger defects, standard practice is to allow delayed healing by secondary intention.

The use of Alloderm graft placement for donor site coverage was first described in Armenakas' group. Alloderm is an acellular dermal lattice from human allograft skin. The only study to report the use of Alloderm failed to find a significant improvement in patient outcomes; however, very small defects were included in this study and the control group underwent primary closure, which has been shown to be inferior for large defects. Importantly, no increase in post-operative pain was noted, although there was some increased swelling reported. From experience, patients with moderate and large (>2 cm width) defects following buccal mucosa harvest benefit from Alloderm placement with decreased post-operative pain, more rapid resumption of normal diet and mouth function with no associated increase in morbidity of the procedure. This study aims to determine whether this is a reliable improvement in technique.

This study will clarify how the cheek heals after the buccal mucosa is removed during reconstructive surgery. Subjects will be randomized to either receive tissue collagen matrix or no stitches after the surgery. Subjects will be evaluated up to six months to determine if the outcomes of the tissue matrix graft are better for the subject.

研究概览

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10016
        • New York University Langone Medical Center

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

男性

描述

Inclusion Criteria:

  • >18 years of age
  • Male
  • Patients with clinically necessary buccal mucosal graft >2 cm
  • Patients who are able to present for pre-operative and post-operative evaluations
  • Patients who are able to comprehend and read English

Exclusion Criteria:

  • History of oral cancer
  • Severe cognitive impairments
  • Unwilling or unable to follow procedures in protocol
  • Contraindicated to participate for any reason

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Tissue Matrix Graft Placement
After the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix
Subject will receive a covering for the wound post buccal mucosa removal.
有源比较器:Without stitches
After the buccal mucosa is removed during reconstructive surgery, no stitches will be used for the wound to heal.
Subject will not receive stitches post buccal mucosa removal.

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
Pain Level
大体时间:Six months
Measured by the Visual Analog Scale
Six months

次要结果测量

结果测量
措施说明
大体时间
Time to Normal Eating
大体时间:Six Months
This is measured by time.
Six Months
Presence of Swelling
大体时间:Six Months
This is measured by time
Six Months
Mouth mobility
大体时间:Six Months
This is measured by time
Six Months
Presence of Paresthesia
大体时间:Six Months
This is measured by time
Six Months

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:Lee Zhao, MD、NYU Langone Health

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 (实际的)

2017年4月10日

初级完成 (实际的)

2018年4月9日

研究完成 (实际的)

2018年4月9日

研究注册日期

首次提交

2016年5月9日

首先提交符合 QC 标准的

2016年5月10日

首次发布 (估计)

2016年5月11日

研究记录更新

最后更新发布 (实际的)

2019年6月5日

上次提交的符合 QC 标准的更新

2019年6月3日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 16-00669

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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.

3
订阅