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RECRUITING
NCT06825039
NA

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

Sponsor: Universiteit Antwerpen

View on ClinicalTrials.gov

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).

Official title: The Effects of Extracorporeal Shock Wave Therapy in Different Stages of Scar Formation in Postsurgical Scars Especially After Abdominplasty and Breast Reduction.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-12-20

Completion Date

2027-02

Last Updated

2025-03-06

Healthy Volunteers

No

Interventions

DEVICE

Shockwave therapy

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.

Locations (4)

Ziekenhuis aan de Stroom

Antwerp, Antwerp, Belgium

Heilig Hart Ziekenhuis Lier

Lier, Antwerp, Belgium

AZ Rivierenland Rumst

Rumst, Antwerp, Belgium

Universitair Ziekenhuis

Wilrijk, Antwerp, Belgium