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临床试验/NCT01445990
NCT01445990已完成不适用

Evaluation of Free Tissue Flaps Viability With Capillary Glucose and Lactate Measurements Compared With Clinical Examination

Narcisse Zwetyenga4 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
4
主要终点
Clinical examination of the flap

研究概览

简要总结

Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments diagnosis in free tissue transfers is realized.

These measures are done after surgical reconstructions with free tissue flap, simultaneously with clinical examination. These biological data aren't available to make clinical diagnosis of complication; only clinical examination is allowed in this way.

A posteriori, clinical and biological parameters will be compared in order to determine if capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps monitoring.

详细描述

Free tissue flap reconstruction has become a reliable technique. Nevertheless, pedicle thrombosis is dreaded, and the earlier the diagnosis of such complications is made, the higher the surgical salvage rate is.

Clinical monitoring remains the most useful and used monitoring method, but makes late and unreliable diagnosis. Numerous studies are searching for ideal monitoring technics with regard to free flaps. Nowadays, the most efficient ones often deal with expensive and invasive technics. In this study, capillary lactataemia and glycaemia measurements are evaluated for pedicle impairments diagnosis.

Measurements of these 2 biological parameters seem to be a powerful screening test of pedicle impairments in microdialysis. But these parameters are measured in this case in interstitial tissues. Capillary measurements will probably provide different results, and needs to be evaluated.

For that purpose, surgical reconstructions with free tissue flap will be clinically monitored during five days, every hours for the first 24 hours, and every 4 hours for the next 4 days. Simultaneously, blind measurements of capillary lactataemia and glycaemia will be performed. Biological and clinical data will be systematically written in the corresponding table of the individual register together with the time the examination is done.

In this register, all complications and evolutions of the flaps will be recorded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Care Provider)

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

  • •Informed patient
  • •Signed informed consent
  • •Free tissue flap reconstruction
  • •Accessible flap for measurements

排除标准

  • •Pregnancy
  • •Patient under 18
  • •Unaccessible flap

结局指标

主要结局

Clinical examination of the flap

时间窗: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose and lactate measurements.

Clinical examination is done immediately after the end of the surgical procedure (Expected 1 to 5 hours after the end of arterial anastomosis). Then, examinations are done every hours for the first 24 hours, and every 4 hours for the next 4 days. The clinical examination was standardized: skin paddle colour and temperature, skin reperfusion time, and bleeding test with a prick. In order to avoid bias, examinations are performed by caregivers before capillary lactate and glucose measurements, and they hadn't any information about expected results of lactate and glucose values.

次要结局

  • Capillary lactate measurements(Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose measurements and clinical examinations.)
  • Capillary glucose measurements(Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary lactate measurements and clinical examinations.)

研究者

发起方
Narcisse Zwetyenga
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Narcisse Zwetyenga

Head of Maxillo-Facial, Plastic and Reconstructive Surgery Unit

Centre Hospitalier Universitaire Dijon

研究点 (4)

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