A Prospective Single-center Study for Evaluation of the Effectiveness of Pulsed Acoustic Cellular Expression Technology on Post-Operative Soft Tissue Fibrosis.
Northwestern University
Summary
This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.
Description
This study was conducted as a single-blind, randomized controlled trial (RCT) to evaluate the efficacy of acoustic shockwave therapy in treating post-surgical fibrosis following breast reconstruction. The intervention period spanned four weeks, during which participants received a total of eight treatment sessions-two sessions per week. Participants returned for follow-up evaluation at three months. Patients were randomized to either the intervention arm, which received active shockwave therapy, or the control arm, which received a sham (placebo) version of the therapy. Randomization was perfo…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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. * Pr…
Interventions
- DevicePulsed Acoustic Cellular Expression therapy
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.
Location
- Lavin Pavilion Suite 2060Chicago, Illinois