Pilot Study of Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Time to wound healing / Scar maturation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-45 and 55-85 years, respectively
排除标准
- •past medical history of hypertrophic scarring or keloid disease
- •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
- •Inclusion Criteria:
- •age 18-45 and 55-85 years, respectively
- •normal and/or hypertrophic scars
- •Baux score <100
- •Exclusion Criteria:
- •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
- •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
- •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
结局指标
主要结局
Time to wound healing / Scar maturation
时间窗: day14, day90, day180
次要结局
未报告次要终点
研究者
David Lumenta, MD
Dr
Medical University of Vienna