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

NCT06825039 | Recruiting

• 2 other identifiers: 11B8619N(BELGIUM)2613
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Scar; Shockwave Therapy

Keywords

Skin scars, Post surgical, Underlying mechanisms, Shock wave

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (5)

• 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

• Quality of life assessment in scar-affected Individuals

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

• Quality of life assessment in scar-affected Individuals

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

Study Arms (5)

Group 3

EXPERIMENTAL

* Intensity: 0.07mJ/mm2 * Number of shocks: 100 impulses/cm2 * Frequency: 2 Hz * Treatment frequency: 1x/week * Total amount of treatments: 10 treatments

Device: Shockwave therapy

Group 5

EXPERIMENTAL

* Intensity: 0.25mJ/mm2 * Number of shocks: 100 impulses/cm2 * Frequency: 8 Hz * Treatment frequency: 1x/week * Total amount of treatments: 10 treatments

Device: Shockwave therapy

Group 1

NO INTERVENTION

Control group

Group 2

NO INTERVENTION

Control group

Group 4

EXPERIMENTAL

* Intensity: 0.07mJ/mm2 * Number of shocks: 100 impulses/cm2 * Frequency: 2 Hz * Treatment frequency: 1x/week * Total amount of treatments: 10 treatments

Device: Shockwave therapy

Interventions

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.

Group 3; Group 4; Group 5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients aged between 18 and 80 years
• Dutch or English speaking
• Patients who had undergone an abdominoplasty resulting in a dermal scar

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Heilig Hart Ziekenhuis Lier: collaborator
• University Hospital, Antwerp: collaborator
• Ziekenhuis Rivierenland: collaborator
• AZ Middelheim, Antwerpen: collaborator

Study Sites (4)

Ziekenhuis aan de Stroom

Antwerp, Antwerp, 2030, Belgium

RECRUITING

Heilig Hart Ziekenhuis Lier

Lier, Antwerp, 2500, Belgium

RECRUITING

AZ Rivierenland Rumst

Rumst, Antwerp, 2840, Belgium

RECRUITING

Universitair Ziekenhuis

Wilrijk, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Cicatrix

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Lot Demuynck

CONTACT

+32496204106; lot.demuynck@uantwerpen.be

Ulrike Van Daele

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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. 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. Concept of low-energy treatments for group 3 (ESWT 1) and 4 (ESWT 2): * Intensity: 0.07mJ/mm2 * Number of shocks: 100 impulses/cm2 * Frequency: 2 Hz * Treatment frequency: 1x/week * Total amount of treatments: 10 treatments Concept of high-energy treatments for group 5 (ESWT 3): * Intensity: 0.25mJ/mm2 * Number of shocks: 100 impulses/cm2 * Frequency: 8 Hz * Treatment frequency: 1x/week * Total amount of treatments: 10 treatments The scarred area is prepared with contact-gel to conduct the shock waves. The investigators treat scars after full wound closure.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: February 13, 2025
• Study Start: December 20, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)