NCT06825039 The Effects of Extracorporeal Shock Wave Therapy in Postsurgical Scars Especially After Abdominplasty and Breast Reduction.
| NCT ID | NCT06825039 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiteit Antwerpen |
| Condition | Scar |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-12-20 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-12-20 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion criteria * 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 Exclusion criteria * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06825039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Scar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06825039 currently recruiting?
Yes, NCT06825039 is actively recruiting participants. Contact the research team at lot.demuynck@uantwerpen.be for enrollment information.
Where is the NCT06825039 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Lier, Belgium, Rumst, Belgium, Wilrijk, Belgium.
Who is sponsoring the NCT06825039 clinical trial?
NCT06825039 is sponsored by Universiteit Antwerpen. The trial plans to enroll 150 participants.