Can a daily supplement stop breast implant scarring?
NCT ID NCT06785610
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a daily dietary supplement called Capsulase can prevent capsular contracture, a condition where scar tissue tightens around breast implants, causing pain and distortion. One hundred women who had a mastectomy and immediate implant reconstruction took the supplement after surgery. Researchers will compare their rate of capsular contracture at one year to historical data from patients who did not take the supplement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Capsulase (dietary supplement)
- What this could lead to
- If it works, this could offer a simple, non-drug way to prevent a common complication after breast implant surgery.
- What could go wrong
- This is a small, early study without a control group, so results are preliminary. The supplement may not prove effective in larger, more rigorous trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Immediate post mastectomy reconstruction with definitive silicone implant (microtextured prosthesis) (both therapeutic and risk reducing mastectomies) * Informed consent * Unilateral and bilateral mastectomies Exclusion Criteria: * Hypersensitivity to Capsulase® * Pregnant women * Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality) * Patients with previous breast implants * Revisional surgery for capsular contracture * Use of micro polyurethane foam-coated implants * Mesh and matrix-assisted reconstructions * Reconstruction of previous irradiated breasts
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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European Institute of Oncology
Milan, 20141, Italy