Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06825039

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

Led by Universiteit Antwerpen · Updated on 2025-03-06

150

Participants Needed

4

Research Sites

162 weeks

Total Duration

On this page

Sponsors

U

Universiteit Antwerpen

Lead Sponsor

H

Heilig Hart Ziekenhuis Lier

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 80 years
  • Able to speak Dutch or English
  • Patients who have had an abdominoplasty resulting in a dermal scar
  • Informed consent provided before surgical intervention
Not Eligible

You will not qualify if you...

  • Any type of skin disease or dermatological problem
  • Previous surgery or ESWT treatment at the current scar site
  • Age under 18 years or over 80 years
  • Unable to provide informed consent
  • Expected problems with therapy compliance or follow-up
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Ziekenhuis aan de Stroom

Antwerp, Antwerp, Belgium, 2030

Actively Recruiting

2

Heilig Hart Ziekenhuis Lier

Lier, Antwerp, Belgium, 2500

Actively Recruiting

3

AZ Rivierenland Rumst

Rumst, Antwerp, Belgium, 2840

Actively Recruiting

4

Universitair Ziekenhuis

Wilrijk, Antwerp, Belgium, 2650

Actively Recruiting

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Research Team

L

Lot Demuynck

CONTACT

U

Ulrike Van Daele

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NA

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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