The Effects of Extracorporeal Shock Wave Therapy in Postsurgical Scars Especially After Abdominplasty and Breast Reduction.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversiteit Antwerpen

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shockwave therapy

    Device

    Focused ESWT will be applied to the scarred area in the 3 intervention groups. Each group will receive 10 ESWT treatments with a frequency of 1x/week. Energy levels (EFD mJ/mm2) or bar in radial can range between 0.01-0.33 mJ/mm2 (33). Based upon experimental papers, the described energy flux density, frequency and number of shots should activate or modulate the signaling pathways of interest and are used in the treatment of scars.

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: Group 3Experimental treatment 1 intervention
Group B: Group 5Experimental treatment 1 intervention
Group C: Group 1No intervention 0 interventions
Group D: Group 2No intervention 0 interventions
Group E: Group 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in α-SMA and myofibroblasts

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.

Time frame
baseline: 2weeks and 6 weeks OR 6 weeks and 3 weeks
2

Change in Macrophages

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.

Time frame
baseline: 2weeks and 6 weeks OR 6 weeks and 3 weeks
3

Change in TGF-β

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.

Time frame
baseline: 2weeks and 6 weeks OR 6 weeks and 3 weeks
4

Change in collagen type I en type III

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.

Time frame
baseline: 2weeks and 6 weeks OR 6 weeks and 3 weeks

Secondary outcomes

1

Measurement of color changes in scar tissue

Colour will be measured using a Mexameter MX18 (from Courage and Khazaka) using the erythema/melanin indices. The Mexameter uses 16 light-emitting diodes that emit light at three wavelengths (green: 568 nm; red 660 nm; infrared 880 nm). Then, the reflected light is measured by a receiver unit. Erythema is measured by the green and red wavelengths, whereas melanin is determined by the red and infrared wavelengths.

Time frame
baseline: 2 weeks - 6 weeks - 3 months - 6 months
2

Measurement of vertical elasticity changes in scar tissue

Vertical elasticity will be measured using a Cutometer Dual MPA 580®(from Courage and Khazaka). The cutometer uses a negative pressure where after the skin is drawn into the aperture of the probe.

Time frame
baseline: 2 weeks - 6 weeks - 3 months - 6 months
3

Patient-reported outcomes on scar characteristics

The patient observer scar assessment scale is a two numerical scar assessment scale whereby the patient and observer evaluate the scar. The observer scar assessment scale-observer scale (POSAS-O 3.0) is filled in by the investigator. POSAS-P 3.0 (patient) is filled in by the patient and is a reliable instrument. A total of 16 or 17 items in the generic and linear questionnaire, aimed at measuring visual (e.g., color), tactile (e.g., pliability), and sensory (e.g., itching) characteristics of the scar. Additionally, there is 1 item regarding overall satisfaction with the scar (this item is excluded from the scoring). Each item is rated on a scale from 0 to 10, where 0 represents the best possible outcome (no scar or no issues) and 10 represents the worst possible outcome (severe issues with the scar).

Time frame
baseline: 2 weeks - 6 weeks - 3 months - 6 months - 1 year
4

Quality of life assessment in scar-affected Individuals

The Dermatology Life Quality Index (DLQI) is a questionnaire to define patient satisfaction. It quantifies the health-related quality of life of the patient by measuring the disability caused by any skin disease. The DLQI consists of 10 questions, each addressing a different aspect of how the skin condition affects the patient's life. Each question is scored on a scale from 0 to 3, where: 0 = "Not at all" (no impact); 1 = "A little" (small impact); 2 = "A lot" (moderate to significant impact); 3 = "Very much" (severe impact). The maximum possible score is 30 (if all answers are "3"). The minimum possible score is 0 (if all answers are "0"). Interpreting the DLQI Score: 0-1: No effect on quality of life 2-5: Small effect on quality of life 6-10: Moderate effect on quality of life 11-20: Very large effect on quality of life 21-30: Extremely large effect on quality of life

Time frame
baseline: 2 weeks - 6 weeks - 3 months - 6 months - 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiteit Antwerpen

Lead sponsor

Heilig Hart Ziekenhuis Lier

Collaborator

University Hospital, Antwerp

Collaborator

Ziekenhuis Rivierenland

Collaborator

AZ Middelheim, Antwerpen

Collaborator