Breast Implant; ComplicationsRTADMNCT06139588
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction
An observational study of Breast Implant; Complications and Breast Implant Infection, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Implant; Complications, Breast Implant Infection, Implant Capsular Contracture
- What is being tested?
- acellular dermal matrix implant for breast reconstruction
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 13 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The study focuses on female patients undergoing implant based reconstruction after radiotherapy assisted by the use of an acellular dermal matrix.
Who may be able to join
- at least 6 months follow up
- breast reconstruction with implant + acellular dermal matrix after mastectomy and radiotherapy
Who cannot join
- mastectomy flap <1 cm
- autoimmune disease
- prolonged use of corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Efficacy and Risk Profile of Two Animal-derived Acellular Dermal Matrices in Patients Undergoing Mastectomy, Radiotherapy and Implant-based Reconstruction
The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss)
The main questions the study aims to answer are:
Read more
- is one of the two matrices better than the other? (better results with fewer complications)
- is there a group of patients who benefit more than another from the use of this type of devices?
- is there an adm which works better in one specific subgroup of patients? Participants have undergone mastectomy, radiotherapy and implant reconstruction with the aid of two different kinds of acellular dermal matrices.
Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.
Read the detailed description
Radiotherapy is highly effective in breast cancer treatment, yet it impairs satisfactory implant-based reconstruction, due to high rates of capsular contracture and implant loss. This said, a fervent investigtion exists upon solutions that can make implant-based reconstruction safer and aesthetically satisfying, including the use of acellular dermal matrices. We retrospectively want to analyze our ADM-assisted post-RT implant-based breast reconstructions comparing two different matrices (porcine and bovine), when autologous reconstruction was contraindicated, to assess eventual differences in efficacy and risk profile of the devices. We want to further stratify the population in 4 groups based on clinical presentation to assess if there was a group where ADMs proves to perform better (Group A - previous quadrantectomy, Group B - previous mastectomy and expander reconstruction, Group C - previous mastectomy and implant reconstruction, Group D - prior quadrantectomy followed by mastectomy and implant reconstruction).
- Conditions
- Breast Implant; Complications, Breast Implant Infection, Implant Capsular Contracture, Breast Seroma, Breast Implant Protrusion, Breast Cancer
- Being tested
- acellular dermal matrix implant for breast reconstruction
- Keywords
- implant-based, breast reconstruction, adm, radiation therapy, irradiated breast
- Medical subject headings
- Implant Capsular Contracture, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acellular dermal matrix implant for breast reconstructionDevice
acellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| POST QUART NATIVE | Native adm used in the setting of mastectomy and implant reconstruction after QUART Receives: Device: acellular dermal matrix implant for breast reconstruction | |
| POST QUART VERITAS | Veritas adm used in the setting of mastectomy and implant reconstruction after QUART Receives: Device: acellular dermal matrix implant for breast reconstruction | |
| POST EXPANDER NATIVE | Native adm used in the setting of expander removal and implant positioning after mastectomy + RT Receives: Device: acellular dermal matrix implant for breast reconstruction | |
| POST EXPANDER VERITAS | Veritas adm used in the setting of expander removal and implant positioning after mastectomy + RT Receives: Device: acellular dermal matrix implant for breast reconstruction | |
| IMPLANT EXCHANGE NATIVE | Native adm used in the setting of implant exchange after mastectomy + RT Receives: Device: acellular dermal matrix implant for breast reconstruction | |
| IMPLANT EXCHANGE VERITAS | Veritas adm used in the setting of implant exchange after mastectomy + RT Receives: Device: acellular dermal matrix implant for breast reconstruction | |
| IMPANT EXCHANGE AFTER QUART NATIVE | Native adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction Receives: Device: acellular dermal matrix implant for breast reconstruction | |
| IMPLANT EXCHANGE AFTER QUART VERITAS | Veritas adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction Receives: Device: acellular dermal matrix implant for breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADM efficacy and risk profile comparison
Does one dermal matrix perform better than the other in terms of efficacy and complication rates?
Measured: 60 months
Secondary outcomes (1)
Best clinical setting for ADM use
Is there a subgroup of patient where the use of ADM proves more beneficial than others?
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jun 2017
- Primary completion31 Dec 2022
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant; ComplicationsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Vittorio Emanuele Lisa, MD, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139588
- Sponsor's protocol ID
- UID4321
- Acronym
- RTADM
- Status last verified
- Oct 2023
- First submitted
- 15 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy and Risk Profile of Two Animal-derived Acellular Dermal Matrices in Patients Undergoing Mastectomy, Radiotherapy and Implant-based Reconstruction
- ClinicalTrials.gov ID
- NCT06139588
- Acronym / sponsor ID
- RTADM / UID4321
- Conditions
- Breast Implant; Complications, Breast Implant Infection, Implant Capsular Contracture, Breast Seroma, Breast Implant Protrusion, Breast Cancer
- Keywords
- implant-based, breast reconstruction, adm, radiation therapy, irradiated breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 18 Nov 2023 (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 goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss)
The main questions the study aims to answer are:
- is one of the two matrices better than the other? (better results with fewer complications)
- is there a group of patients who benefit more than another from the use of this type of devices?
- is there an adm which works better in one specific subgroup of patients? Participants have undergone mastectomy, radiotherapy and implant reconstruction with the aid of two different kinds of acellular dermal matrices.
Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.
Detailed description
Radiotherapy is highly effective in breast cancer treatment, yet it impairs satisfactory implant-based reconstruction, due to high rates of capsular contracture and implant loss. This said, a fervent investigtion exists upon solutions that can make implant-based reconstruction safer and aesthetically satisfying, including the use of acellular dermal matrices. We retrospectively want to analyze our ADM-assisted post-RT implant-based breast reconstructions comparing two different matrices (porcine and bovine), when autologous reconstruction was contraindicated, to assess eventual differences in efficacy and risk profile of the devices. We want to further stratify the population in 4 groups based on clinical presentation to assess if there was a group where ADMs proves to perform better (Group A - previous quadrantectomy, Group B - previous mastectomy and expander reconstruction, Group C - previous mastectomy and implant reconstruction, Group D - prior quadrantectomy followed by mastectomy and implant reconstruction).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| POST QUART NATIVE | – | Device: acellular dermal matrix implant for breast reconstructionNative adm used in the setting of mastectomy and implant reconstruction after QUART |
| POST QUART VERITAS | – | Device: acellular dermal matrix implant for breast reconstructionVeritas adm used in the setting of mastectomy and implant reconstruction after QUART |
| POST EXPANDER NATIVE | – | Device: acellular dermal matrix implant for breast reconstructionNative adm used in the setting of expander removal and implant positioning after mastectomy + RT |
| POST EXPANDER VERITAS | – | Device: acellular dermal matrix implant for breast reconstructionVeritas adm used in the setting of expander removal and implant positioning after mastectomy + RT |
| IMPLANT EXCHANGE NATIVE | – | Device: acellular dermal matrix implant for breast reconstructionNative adm used in the setting of implant exchange after mastectomy + RT |
| IMPLANT EXCHANGE VERITAS | – | Device: acellular dermal matrix implant for breast reconstructionVeritas adm used in the setting of implant exchange after mastectomy + RT |
| IMPANT EXCHANGE AFTER QUART NATIVE | – | Device: acellular dermal matrix implant for breast reconstructionNative adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction |
| IMPLANT EXCHANGE AFTER QUART VERITAS | – | Device: acellular dermal matrix implant for breast reconstructionVeritas adm used in the setting of implant exchange after QUART+ Mastectomy and implant reconstruction |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study focuses on female patients undergoing implant based reconstruction after radiotherapy assisted by the use of an acellular dermal matrix.
Key inclusion criteria (2 listed)
- at least 6 months follow up
- breast reconstruction with implant + acellular dermal matrix after mastectomy and radiotherapy
Key exclusion criteria (3 listed)
- mastectomy flap <1 cm
- autoimmune disease
- prolonged use of corticosteroids
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 |
|---|---|---|
| acellular dermal matrix implant for breast reconstructionacellular dermal matrix implant in implant-based breast reconstruction in patients receiving radiotherapy | Device | IMPANT EXCHANGE AFTER QUART NATIVE, IMPLANT EXCHANGE AFTER QUART VERITAS, IMPLANT EXCHANGE NATIVE, IMPLANT EXCHANGE VERITAS, POST EXPANDER NATIVE, POST EXPANDER VERITAS, POST QUART NATIVE, POST QUART VERITAS |
Primary outcome
ADM efficacy and risk profile comparison
Time frame: 60 months
Does one dermal matrix perform better than the other in terms of efficacy and complication rates?
1 secondary outcome
Best clinical setting for ADM use
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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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.
Andrea Vittorio Emanuele Lisa, MD principal investigator
Istituto Europeo di Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant; Complications and Breast Implant Infection, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ADM efficacy and risk profile comparison (time frame: 60 months). 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 13 Dec 2023.