The Effects of Extracorporeal Shock Wave Therapy in Different Stages of Scar Formation in Postsurgical Scars Especially After Abdominplasty and Breast Reduction.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Change in α-SMA and myofibroblasts
研究概览
简要总结
Scars can be caused by physical trauma, surgical incisions, burn injuries and even acne. Deep cutaneous injuries induce pathological scars. Other factors, such as mechanical loading, bacterial colonization are potential factors thought to underlie human hypertrophic and keloid scar formation or contractures. The effect may include functional impairment and aesthetic disadvantages.
Various non-invasive mechanical interventions of physical scar management (e.g. extracorporeal shock wave therapy or ESWT) could have a beneficial influence on wound healing and prevention of hypertrophic scars. ESWT considerably improves the appearance and symptoms of hypertrophic scars. However, the mechanism underlying the observed beneficial effects is not well understood. The objective of the first part of the study is to elucidate the mechanism underlying changes in cellular mechanosensitive pathways that are induced by ESWT. This review will introduce the histopathological effects on ESWT during wound healing and scar development.
The main objective of this study is to determine how much mechanical loading on dermal scars will lead to normal scar healing. The optimal duration, the frequency and the intensity of the applied forces in ESWT to generate a beneficiary effect during different phases of wound healing remains unclear.
In this study, biopsies from abdomionplasty postsurgical scars will be examined. Thereby it is possible to evaluate the outcomes on a cellular level through assessing the histology of human biopsies under controlled condition. In the second part, the underlying mechanism of ESWT on postsurgical scars will be explored, in different stages of wound healing. Furthermore, the investigators will investigate if changes in physical characteristics (redness, thickness and pliability) in postsurgical scars are associated with changes in reactivity of mechanosensitive pathways. This study will close the gap between the fundamental knowledge on cellular mechanotransduction and the clinical application of mechanotherapy during physical scar management (ESWT).
详细描述
- State of the art Every year 80 million scars develop in the world and 40-70% of these will develop into hypertrophic or problematic scars. Moreover, fibrosis and scar formation of the skin pose a substantial physiological and psychological burden on patients. Scars can be caused by physical trauma, surgical incisions, burn injuries and even acne. Most superficial injuries, that do not reach the dermis, do not leave significant scars. However, deep cutaneous injuries can induce pathological scars. Such scars often result in pain, itching, functional impairment, aesthetic disadvantages, anxiety, depression and poor quality of life of the affected person. All these aspects may cause poor functioning during ADL (4). Other aspects, such as uncontrolled mechanical loading, prolonged inflammation, overactive proliferation, bacterial colonization, and foreign-body reaction are potential factors thought to underlie human hypertrophic and keloid scar formation or contractures.
Recent studies have identified that under influence of mechanical load scar proliferation will be prolonged and will even prohibit full maturation of the scar within the foreseen timeframe of two years of wound healing. Mechanical loading can be regarded as any mechanical stress applied to a healing wound, for example imposed forces during physical therapy or tensile forces during activities of daily living. It has been proven that specific sites that are frequently subjected to mechanical load during daily activities have more risk to develop into hypertrophic scars.
Interestingly, mechanical loading cannot only be regarded as a negative predictive factor in scar formation. Under controlled conditions, mechanical load can activate a process called 'mechanotransduction'. Once activated inflammation, proliferation and thereby fibrosis and hypertrophic scarring can be regulated/controlled. Thus, mechanotransduction can be defined as the intracellular conversion of mechanical stimuli into internal chemical signals resulting in gene transcription. This has an effect on the cytoskeleton and the ECM. Signaling pathways are activated or modulated resulting in modification of the affected (scar) tissue.
Various non-invasive mechanical interventions of physical scar management (e.g. extracorporeal shock wave therapy or ESWT, pressure therapy, vacuum massage,..) apply mechanical load and thereby initiate mechanotransduction. Controlled physical scar management can have a beneficial influence on wound healing and prevention of pathological scars. Therefore, this study will focus on the application of mechanical forces in the form of ESWT application. ESWT considerably improves the appearance and symptoms of hypertrophic scars. However, the mechanisms underlying the observed beneficial effects in scar management is not well understood.
To date, there is no consensus concerning the optimal standard of care in scar treatment. Therefore, there is a need to study the underlying mechanism of scarring and the related influence of controlled mechanical forces. 2. Rationale of the study The heterogeneity in causes of scars, the complicated histology of scarring and the numerous intervention possibilities make late-stage clinical research in this field a search for a needle in a haystack. Moreover, it is always difficult to control variables such as location, demographics and genetics in studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients aged between 18 and 80 years
- •Dutch or English speaking
- •Patients who had undergone an abdominoplasty resulting in a dermal scar
- •Informed consent (approved by the ethics committee) will be provided before the surgical intervention
排除标准
- •All type of skin diseases or dermatological problems
- •Previous surgery or ESWT intervention at the current scar site
- •Age under 18 years or above 80 years
- •Inability to provide informed consent
- •Expected problems in therapy compliance or follow up
- •Pregnancy
研究组 & 干预措施
Group 3
- Intensity: 0.07mJ/mm2
- Number of shocks: 100 impulses/cm2
- Frequency: 2 Hz
- Treatment frequency: 1x/week
- Total amount of treatments: 10 treatments
干预措施: Shockwave therapy (Device)
Group 5
- Intensity: 0.25mJ/mm2
- Number of shocks: 100 impulses/cm2
- Frequency: 8 Hz
- Treatment frequency: 1x/week
- Total amount of treatments: 10 treatments
干预措施: Shockwave therapy (Device)
Group 1
Control group
Group 2
Control group
Group 4
- Intensity: 0.07mJ/mm2
- Number of shocks: 100 impulses/cm2
- Frequency: 2 Hz
- Treatment frequency: 1x/week
- Total amount of treatments: 10 treatments
干预措施: Shockwave therapy (Device)
结局指标
主要结局
Change in α-SMA and myofibroblasts
时间窗: baseline: 2weeks and 6 weeks OR 6 weeks and 3 weeks
Scar tissue biopsy specimens will be collected by an experienced plastic surgeon from patients who had undergone an abdominoplasty that registered for the study. The biopsy will be embedded in paraffin for histological examination. After application of local anaesthesia, a 3-4mm diameter punch biopsy will be taken to ensure the presence of the subcutis in the biopsy and to ensure sufficient tissue. After the biopsy has been taken, the small lesion will be closed by a single suture. The investigators are interested in change in α-SMA and myofibroblasts by immunohistochemistry.
Change in Macrophages
时间窗: baseline: 2weeks and 6 weeks OR 6 weeks and 3 weeks
Scar tissue biopsy specimens will be collected by an experienced plastic surgeon from patients who had undergone an abdominoplasty that registered for the study. The biopsy will be embedded in paraffin for histological examination. After application of local anaesthesia, a 3-4mm diameter punch biopsy will be taken to ensure the presence of the subcutis in the biopsy and to ensure sufficient tissue. After the biopsy has been taken, the small lesion will be closed by a single suture. The investigators are interested in change in macrophages by immunohistochemistry.
Change in TGF-β
时间窗: baseline: 2weeks and 6 weeks OR 6 weeks and 3 weeks
Scar tissue biopsy specimens will be collected by an experienced plastic surgeon from patients who had undergone an abdominoplasty that registered for the study. The biopsy will be embedded in paraffin for histological examination. After application of local anaesthesia, a 3-4mm diameter punch biopsy will be taken to ensure the presence of the subcutis in the biopsy and to ensure sufficient tissue. After the biopsy has been taken, the small lesion will be closed by a single suture. The investigators are interested in change in TLR3 by immunohistochemistry.
Change in collagen type I en type III
时间窗: baseline: 2weeks and 6 weeks OR 6 weeks and 3 weeks
Scar tissue biopsy specimens will be collected by an experienced plastic surgeon from patients who had undergone an abdominoplasty that registered for the study. The biopsy will be embedded in paraffin for histological examination. After application of local anaesthesia, a 3-4mm diameter punch biopsy will be taken to ensure the presence of the subcutis in the biopsy and to ensure sufficient tissue. After the biopsy has been taken, the small lesion will be closed by a single suture. The investigators are interested in change in collagen type I en type III by immunohistochemistry.
次要结局
- Quality of life assessment in scar-affected Individuals(baseline: 2 weeks - 6 weeks - 3 months - 6 months - 1 year)
- Measurement of color changes in scar tissue(baseline: 2 weeks - 6 weeks - 3 months - 6 months)
- Measurement of vertical elasticity changes in scar tissue(baseline: 2 weeks - 6 weeks - 3 months - 6 months)
- Patient-reported outcomes on scar characteristics(baseline: 2 weeks - 6 weeks - 3 months - 6 months - 1 year)
研究者
Ulrike Van Daele
Principal Investigator
Universiteit Antwerpen
