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

NCT06825039 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Heilig Hart Ziekenhuis Lier

    collaborator UNKNOWN
  • University Hospital, Antwerp

    collaborator OTHER
  • Ziekenhuis Rivierenland

    collaborator OTHER
  • AZ Middelheim, Antwerpen

    collaborator UNKNOWN
  • Universiteit Antwerpen

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06825039 on ClinicalTrials.gov