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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Eligible patients aged between 18 and 80 years

• Dutch or English speaking

• Patients who had undergone an abdominoplasty resulting in a dermal scar

Locations
Other Locations
Belgium
Ziekenhuis aan de Stroom
RECRUITING
Antwerp
Heilig Hart Ziekenhuis Lier
RECRUITING
Lier
AZ Rivierenland Rumst
RECRUITING
Rumst
Universitair Ziekenhuis
RECRUITING
Wilrijk
Contact Information
Primary
Lot Demuynck
lot.demuynck@uantwerpen.be
+32496204106
Backup
Ulrike Van Daele
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2027-02
Participants
Target number of participants: 150
Treatments
Experimental: Group 3
* Intensity: 0.07mJ/mm2~* Number of shocks: 100 impulses/cm2~* Frequency: 2 Hz~* Treatment frequency: 1x/week~* Total amount of treatments: 10 treatments
Experimental: Group 5
* Intensity: 0.25mJ/mm2~* Number of shocks: 100 impulses/cm2~* Frequency: 8 Hz~* Treatment frequency: 1x/week~* Total amount of treatments: 10 treatments
No_intervention: Group 1
Control group
No_intervention: Group 2
Control group
Experimental: Group 4
* Intensity: 0.07mJ/mm2~* Number of shocks: 100 impulses/cm2~* Frequency: 2 Hz~* Treatment frequency: 1x/week~* Total amount of treatments: 10 treatments
Related Therapeutic Areas
Sponsors
Collaborators: AZ Middelheim, Antwerpen, University Hospital, Antwerp, Heilig Hart Ziekenhuis Lier, Ziekenhuis Rivierenland
Leads: Universiteit Antwerpen

This content was sourced from clinicaltrials.gov