Shockwave in Postoperative Breast Reconstruction Fibrosis
A Prospective Single-center Study for Evaluation of the Effectiveness of Pulsed Acoustic Cellular Expression Technology on Post-Operative Soft Tissue Fibrosis.
Northwestern University
100 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
Summary
This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.
Eligibility
Inclusion Criteria2
- Subjects greater than 18 years of age.
- Subjects who have undergone plastic surgery procedures and present in the post-operative period with soft tissue firmness suggestive of subcutaneous/parenchymal fibrosis.
Exclusion Criteria5
- Subjects with cardiac pacemakers
- Other medical or psychiatric condition that may increase the risk associated with study participation, may complicate subject compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- Proximity of fibrotic tissue directly adjacent to bone
- Face/neck areas are excluded
- Patients who, in the opinion of the investigator, would not be compliant with the schedule of study visits
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Interventions
The therapy involves the delivery of targeted acoustic energy that initiates cellular mechanotransduction pathways, inducing beneficial biological responses such as enhanced angiogenesis, modulation of fibroblast proliferation and differentiation, and reorganization of aberrant extracellular matrix components.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06919042