跳至主要内容
临床试验/NCT00633503
NCT00633503已完成不适用

Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
detection of flap complications by modulated imaging compared to clinical standards

研究概览

简要总结

Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries & veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps allows for improved results in terms of functionality, aesthetic appearance, and psychological well-being in patients requiring reconstructive surgery after cancer resection or trauma. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.

The purpose of this pilot study is to determine if a novel, unique, portable, non-contact optical imaging device developed at the Beckman Laser Institute called Modulated Imaging (MI) can detect changes in a flap's optical properties, which can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy. The study would also evaluate if changes in the tissue transfer flap's optical properties, as detected by the device could be employed as a monitoring device in the post-operative period after reconstructive surgery. The MI device's detection of specific optical properties of a tissue flap could also potentially be used as a diagnostic tool to predict the likelihood of the development of fat necrosis or flap atrophy in a delayed fashion several months after reconstructive surgery.

Prior animal and clinical studies using similar devices have demonstrated that changes in the total hemoglobin concentration and percentage of oxygenated hemoglobin in the tissue transfer flap can be used to differentiate between arterial and venous occlusion. These other similar devices have been shown to be able to detect venous occlusion prior to clinical manifestations of venous occlusion using standard monitoring methods. This early detection of venous occlusion has important implications. It is well established that early detection and surgical re-exploration and correction of venous occlusion is associated with improved survival and salvage rates of tissue transfer flaps. It has been suggested in the reconstructive literature that the development of fat necrosis and flap atrophy are caused by a relative arterial or venous insufficiency, which could be detected using the MI device prior to the clinical manifestations of these complications.Patients undergoing reconstructive surgery at UCI Medical Center will be recruited for enrollment into the study. The study design requires following the patients and review their medical records in order to determine the clinical outcomes of their reconstructive surgery. The process of review of the medical record will require the review of both the in-patient medical record during the hospitalization in which the reconstructive surgery takes place and the outpatient medical record after surgery in order to observe for the possible development of the acute and delayed complications of reconstructive surgery.

详细描述

Objectives:

  1. To develop a safe, non-contact, intra-operative & post-operative device, which can be used as an adjunct to the clinical evaluation of tissue transfer flaps after reconstructive surgery.
  2. To develop an adjunctive device that can reliably detect and distinguish arterial and venous occlusion before the clinical manifestations of such occlusions, and thus provide the scientific basis for future studies which may use the device to potentially improve the salvage rates after re-exploration for such complications.
  3. To evaluate if changes in the optical properties of tissue transfer flaps during the immediate post-operative period can be used to predict the development of late complications of tissue transfer flaps, such as the development of fat necrosis and/or flap atrophy.

Specific aims:

  1. To record intra-operative and post-operative images of pedicle and free tissue transfer flaps used in reconstructive surgery with a device that shines low energy near infrared light that is spatially modulated into a sinusoidal configuration of amplitude called Modulated Imaging (MI).
  2. To study if the MI device described above is able to collect data regarding the optical properties of the tissue transfer flaps, which can then be used to detect acute post-operative occlusion of the artery or of the vein going to and from the tissue transfer flap.
  3. To study if there is a correlation between the immediate post-operative optical properties of tissue transfer flaps and the development of late complications such as fat necrosis and flap atrophy.

Hypotheses:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients planned to undergo reconstructive surgery using either a pedicle or free tissue transfer flap seen by The Plastic Surgery Service on either an in-patient or outpatient bases.
  • Adult patients that are planned to undergo reconstructive surgery as above and able to receive information regarding the study and provide informed consent to enrollment in the study.
  • Exclusion Criteria
  • All emergency reconstructive surgery patients.
  • Patients planned to undergo radiation therapy in the region of the reconstructive surgery within 6 months after surgery.
  • Patients who develop hypotension requiring the administration of vasopressors either intra-operatively or during the post-operative period prior to discharge from the hospital.
  • Patients who develop clinical signs of a surgical site infection at the location of the tissue transfer flap(s).
  • Patients with the development of post-operative anemia requiring a blood transfusion during the first 72 hours after surgery.
  • Patients with tattooing or pigmented lesions on the tissue transfer flap.
  • Patients who incur injury to the flaps secondary to trauma within 6 months of the reconstructive surgery; with trauma defined as either accidental major trauma resulting in injury to the tissue transfer flap or surgical trauma as a result of further oncologic resection of tissues in close proximity to the tissue transfer flap.
  • Minor under the age of 18 years of age.
  • Patients deemed unable to comprehend and provide informed consent to enrollment into study due to either a cognitive deficit or medical condition.

排除标准

  • 未提供

结局指标

主要结局

detection of flap complications by modulated imaging compared to clinical standards

时间窗: as long as hospital stay (baseline before surgery, 72 hours after surgery and before discharge from hospital)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory R. Evans

Professor

University of California, Irvine

研究点 (2)

Loading locations...

相似试验

Monitoring of Tissue Transfer Flaps by Modulated... | 临床试验