Health TrialsbyHealthPanel

Shockwave in Postoperative Breast Reconstruction Fibrosis

ConditionFibrosis Breast
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorthwestern University

About this trial

This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulsed Acoustic Cellular Expression therapy

    Device

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Subcutaneous Fibrosis Mass

Change in size of subcutaneous fibrosis mass assess clinically by PI, point-of-care ultrasound, caliper measurements, and objective/subjective measures by an observer and the patient. Score values range from 1 to 10 with a higher score indicating a worse outcome.

Time frame
One month

Secondary outcomes

1

Pain Score

Pain scores and change. Subjects who presented with shoulder mobility issues complete the DASH questionnaire. Score values range from 1 to 5 with a higher score indicating greater pain.

Time frame
One month
2

Adverse Events

Any adverse events associated with the focused shockwave therapy

Time frame
Three months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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