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Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals (RESOLVE)

2013年11月10日 更新者:David Lumenta, MD、Medical University of Vienna

Pilot Study of Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals

Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation, proliferation, maturation and remodelling.

In the young, damage to an organ mostly triggers fully regenerative mechanisms called "primary" wound healing. Repeated damage in young individuals may cause "secondary" wound healing eg. scar formation reflecting a rescue program, in which reorganisation has failed.

Organ failure in the ageing organism is characterized by a progressive loss of its capability to achieve an orderly reactivation of organ repair, and results in a combination of chronic inflammation and fibroproliferative, non-regenerative repair affecting several organs, including lung, liver and skin.

RESOLVE's objective is to identify, characterize, and validate molecular targets responsible for shifting primary organ repair towards fibroproliferative wound healing as a result of an age-dependent loss of regulatory control.

The structured approach is based on

  • different forms of wound healing,
  • different human diseases and
  • different genetic backgrounds,

aiming to provide future diagnostic tools in various organs, to create transgenic animal test systems, and to identify molecular targets involved in fibroproliferative wound healing.

研究概览

详细说明

Cutaneous scars are frequently encountered conditions. The process of wound repair, however, is complicated, and various factors contribute to different types of scarring (eg. hypertrophic, atrophic).

WP 2.1: Regular skin repair

In elective plastic surgery most excised operative skin specimens are usually discarded, and represent an excellent opportunity of harvesting skin biopsies without additional invasive measures. This work package analyzes skin samples of individuals after elective plastic surgery with normal wound healing serving as control group.

WP 2.2: Skin repair with and without hypertrophic scar formation

A classic example of fibroproliferative repair in the skin is hypertrophic scarring classified as a dermal skin lesion, which is raised above skin level, stays within the confines of the initial wound and increases in size by pushing out the margins of the scar without invading the surrounding normal tissue.

Hypertrophic scarring is a condition commonly observed after burns and in regions of prolonged wound healing (>21 days). The underlying pathology of hypertrophic scarring, however, is poorly understood. Hypertrophic scars can be managed conservatively, and only require surgical intervention under special circumstances.

This work package analyzes the clinical and molecular response to a standard treatment regimen in skin regions with and without hypertrophic scars after skin injuries.

WP 2.4: Wound healing in normal and diabetic individuals

Diabetes mellitus is a known factor to cause impaired wound healing. Due to microangiopathic, macroangiopathic and other conditions resulting from atherosclerosis and peripheral neuropathy wound healing in diabetic individuals is usually delayed (hypotrophic, atrophic) and often complicated by immunosuppression and superinfections. The rising prevalence of diabetes mellitus in the elderly population makes it necessary to understand its related processes in relevant clinical wound models.

Split-thickness skin-grafting is a commonly applied technique in plastic surgery, and donor sites of previously uninjured skin regions spontaneously heal within two weeks, representing an ideal condition to monitor clinical and molecular changes in diseased vs. non-diseased states.

This work package analyzes skin repair in donor sites of split-thickness skin grafts in non-diabetic and diabetic individuals.

研究类型

观察性的

注册 (实际的)

51

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

      • Vienna、奥地利、1090
        • Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna

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 至 85年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

WP 2.1 Individuals due for planned elective plastic surgery with regular wound healing

WP 2.2 Individuals, who suffered from burns, trauma or having undergone any type of previous surgery with and without hypertrophic scar formation

WP 2.4 Individuals, who require split-thickness skin grafting for skin defects with or without diabetes mellitus

描述

WP2.1

Inclusion Criteria:

  • age 18-45 and 55-85 years, respectively

Exclusion Criteria:

  • past medical history of hypertrophic scarring or keloid disease
  • cardiac disease adversely affecting peripheral blood flow
  • active neoplastic disease
  • immunosuppressive condition, congenital or acquired
  • anemia
  • autoimmune disorder
  • acute or chronic renal failure
  • liver cirrhosis or active hepatitis
  • active substance-abuse disorder
  • severe underweight (body mass index <16)
  • endocrinological disorder
  • pregnancy or lactation for women of child-bearing age

WP2.2

Inclusion Criteria:

  • age 18-45 and 55-85 years, respectively
  • normal and/or hypertrophic scars
  • Baux score <100

Exclusion Criteria:

  • sepsis
  • electrical and/or chemical burn
  • clinically significant wound infection in areas of planned biopsies
  • cardiac disease adversely affecting peripheral blood flow
  • active neoplastic disease
  • immunosuppressive condition, congenital or acquired
  • autoimmune disorder
  • acute or chronic renal failure
  • liver cirrhosis or active hepatitis
  • active substance-abuse disorder
  • severe underweight (body mass index <16)
  • endocrinological disorder
  • pregnancy or lactation for women of child-bearing age

WP 2.4

Inclusion Criteria:

  • age 18-45 and 55-85 years, respectively

Exclusion Criteria:

  • cardiac disease adversely affecting peripheral blood flow
  • active neoplastic disease
  • immunosuppressive condition, congenital or acquired
  • anemia
  • autoimmune disorder
  • acute or chronic renal failure
  • liver cirrhosis or active hepatitis
  • substance-abuse disorder
  • severe underweight (body mass index <16)
  • thyroid function disorder
  • pregnancy or lactation for women of child-bearing age

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

  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Regular wound healing, young
Regular skin repair, controlled wound healing conditions in young individuals
Taken from regularly discarded tissue during routine operation
Blood taking on day 0
Blood taking on day 90
Regular wound healing, aged
Regular skin repair, controlled wound healing conditions in aged individuals
Taken from regularly discarded tissue during routine operation
Blood taking on day 0
Blood taking on day 90
Hypertrophic scarring, young
Skin repair with and without hypertrophic scarring in young individuals
Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
Hypertrophic scarring, aged
Skin repair with and without hypertrophic scarring in aged individuals
Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
Non-diabetic, young
Skin repair in non-diabetic young individuals
Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
Non-diabetic, aged
Skin repair in non-diabetic aged individuals
Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
Diabetic, young
Skin repair in young diabetic individuals
Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
Diabetic, aged
Skin repair in aged diabetic individuals
Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Time to wound healing / Scar maturation
大体时间:day14, day90, day180
day14, day90, day180

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。

合作者

调查人员

  • 首席研究员:Lars P Kamolz, MD, MSc、MUW

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2009年7月1日

初级完成 (实际的)

2011年7月1日

研究注册日期

首次提交

2009年12月28日

首先提交符合 QC 标准的

2009年12月28日

首次发布 (估计)

2009年12月29日

研究记录更新

最后更新发布 (估计)

2013年11月13日

上次提交的符合 QC 标准的更新

2013年11月10日

最后验证

2013年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • FP7-202047.WP.2.1-2.2-2.4
  • MUW-EK-Nr_015/2009 (其他标识符:MUVienna)

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.

Skin sample的临床试验

3
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