Capsular Contracture Associated With ImplantNCT06785610
Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions
A study testing Capsulase® in people with Capsular Contracture Associated With Implant, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The study plans to evaluate capsular contracture at 1-year follow-up in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Capsular Contracture Associated With Implant
- What is being tested?
- Capsulase®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Immediate post mastectomy reconstruction with definitive silicone implant (microtextured prosthesis) (both therapeutic and risk reducing mastectomies)
- Informed consent
- Unilateral and bilateral mastectomies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Single-arm Prospective Study to Evaluate Capsulase for Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions
The study plans to evaluate capsular contracture at 1-year follow-up in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period. These data are compared with historical data of capsular contracture in patients not receiving any food supplementation postoperatively.
Aim of the study is to collect preliminary data to support Capsulase® supplementation in the postoperative period to prevent capsular contracture.
Read the detailed description
Capsular contracture is one of the most common complications of breast implant use, in both reconstructive and aesthetic setting. Research on capsular contracture has focused on reducing bacterial contamination of implant surfaces through antibiotic and antiseptic solutions and, more recently, on the pharmacological control of the inflammation process around the implant. The foreign body reaction is responsible for capsular contracture.
Several experimental studies have demonstrated that it is possible to pharmacologically control the inflammation process around implants reducing the profibrotic substances included in the inflammation pathway.
Among diet supplements there are several substances that have been studied for their anti-inflammatory properties, in particular omega-3 fatty acids and boswellic acids.
Capsulase® is a diet supplement and consists of Boswellia serrata phospholipid INDENA®, palmitoylethanolamide (PEA), quercetin phytosome INDENA®, bromelain 2500 Gelatin Dissolving Units/gram (GDU/g) and vitamin E acetate. Its efficacy and safety in women with contracted breast implants have been evaluated both in the reconstructive and aesthetic setting. Although preliminary results are satisfactory, however the series include a small sample of women.
Aim of this study is to collect preliminary data to support Capsulase® supplementation in the postoperative period to prevent capsular contracture, comparing capsular contracture in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period with historical data of capsular contracture in patients not receiving any food supplementation postoperatively.
- Being tested
- Capsulase®
- Keywords
- Capsular Contracture, Mastectomy reconstruction, Definitive silicone implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsulase®Dietary supplement
Capsulase® supplement daily administration after surgery
| Study group | Role | What they receive |
|---|---|---|
| Capsulase® supplementation | Experimental | Capsulase® supplementation in the postoperative period Receives: Dietary Supplement: Capsulase® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsular contracture rate
Number of capsular contracture at 1-year follow-up
Measured: 1 year
Secondary outcomes (2)
Capsular contracture rate compared to historical data
Capsular contracture rate at 1-year in patients receiving Capsulase® supplementation compared with capsular contracture rate in the historical control arm of patients not receiving any supplementation
Measured: 1 year
Patient satisfaction
Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start8 Apr 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsular Contracture Associated With ImplantStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single-arm prospective study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca De Lorenzi, MD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785610
- Sponsor's protocol ID
- UID 4634
- Other IDs
- L2-269
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm Prospective Study to Evaluate Capsulase for Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions
- ClinicalTrials.gov ID
- NCT06785610
- Acronym / sponsor ID
- UID 4634
- Keywords
- Capsular Contracture, Mastectomy reconstruction, Definitive silicone implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study plans to evaluate capsular contracture at 1-year follow-up in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period. These data are compared with historical data of capsular contracture in patients not receiving any food supplementation postoperatively.
Aim of the study is to collect preliminary data to support Capsulase® supplementation in the postoperative period to prevent capsular contracture.
Detailed description
Capsular contracture is one of the most common complications of breast implant use, in both reconstructive and aesthetic setting. Research on capsular contracture has focused on reducing bacterial contamination of implant surfaces through antibiotic and antiseptic solutions and, more recently, on the pharmacological control of the inflammation process around the implant. The foreign body reaction is responsible for capsular contracture.
Several experimental studies have demonstrated that it is possible to pharmacologically control the inflammation process around implants reducing the profibrotic substances included in the inflammation pathway.
Among diet supplements there are several substances that have been studied for their anti-inflammatory properties, in particular omega-3 fatty acids and boswellic acids.
Capsulase® is a diet supplement and consists of Boswellia serrata phospholipid INDENA®, palmitoylethanolamide (PEA), quercetin phytosome INDENA®, bromelain 2500 Gelatin Dissolving Units/gram (GDU/g) and vitamin E acetate. Its efficacy and safety in women with contracted breast implants have been evaluated both in the reconstructive and aesthetic setting. Although preliminary results are satisfactory, however the series include a small sample of women.
Aim of this study is to collect preliminary data to support Capsulase® supplementation in the postoperative period to prevent capsular contracture, comparing capsular contracture in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period with historical data of capsular contracture in patients not receiving any food supplementation postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm prospective study
| Arm | Type | Receives |
|---|---|---|
| Capsulase® supplementation | Experimental | Dietary Supplement: Capsulase®Capsulase® supplementation in the postoperative period |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Immediate post mastectomy reconstruction with definitive silicone implant (microtextured prosthesis) (both therapeutic and risk reducing mastectomies)
- Informed consent
- Unilateral and bilateral mastectomies
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsulase®Capsulase® supplement daily administration after surgery | Dietary supplement | Capsulase® supplementation |
Primary outcome
Capsular contracture rate
Time frame: 1 year
Number of capsular contracture at 1-year follow-up
2 secondary outcomes
Capsular contracture rate compared to historical data
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
Recruiting
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
Breast Cancer, Capsular Contracture Associated With Breast Implant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca De Lorenzi, MD principal investigator
European Istitute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsulase® in people with Capsular Contracture Associated With Implant, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capsular contracture rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.