Prepectoral Breast ReconstructionIBR-PPBRNCT06216106
Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes
An observational study of Prepectoral Breast Reconstruction and Breast Reconstruction, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Prepectoral Breast Reconstruction, Breast Reconstruction, Radiation Therapy Complication
- What is being tested?
- Prepectoral breast reconstruction with polyurethane implants
- Type of treatment
- Surgery or procedure
- How many people
- 237 participants
- Where
- 1 siteItaly
- Study dates
- 18 Mar 2020to 5 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
- Child, Adult, Older adult
Study population: Patientes undergone immediate prepectoral breast reconstruction with polyurethane implantes
Who may be able to join
- patients underwent prepectoral breast recosntruction with polyurethane implants after skin or nipple sparing masectomy
- adequate mastectomy flap in vascularity and thickness
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prepectoral Breast Reconstruction With Polyurethane Implantes and Radiotherapy: a Single Center Retrospective Study Evaluating Risk and Complications
The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.
Read the detailed description
The study is a data collection of 250 patients for a total of 317 breasts underwent prepectoral breast recosntruction with polyurethane implantes. It is a retrospective study of a single center. The investigators gave indication to that type of reconstruction only to patients with good thickness (> 0.5 cm) and vascularity of skin flap after mastectomy.
The investigators used not selective criteria regarding risk factors so to better evaluate wich of them has a negative trend on the success of the reconstruction and on the major and minor complications. In that way the investigators tried to definde clarly the correct indications for this type of reconstruction.
In addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence.
The investigators decide to perform prepectoral breast reconstruction also in 20 patientes underwent previous radiotherapy dependig on the grade of cutaneus radiodistrophy, so to propose our less invasive approach to these patients normally candidates to autologus breast reconstruction
- Being tested
- Prepectoral breast reconstruction with polyurethane implants
- Keywords
- PPBR, POLYURETHANE, IBR, RADIOTHERAPY, BREAST IMPLANTS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepectoral breast reconstruction with polyurethane implantsProcedure or surgery
Breast reconstruction in the prepectoral plane without elevate the pectoralis major muscle. We choose this type of reconstruction only in patients with mastectomy flap thickness of plus then 0.5 cm. We usally use silicone implants covered by an external layer of polyurethane so not to put directly in contact the silicone with the subcutaneus tissue.
| Study group | Role | What they receive |
|---|---|---|
| patients undergone prepectoral breast reconstruction | As the retrospective nature of this study, we have no exlusion criterias. We included all the patients with prepectoral breast reconstruction with polyurethane covered implants. We also included patients underwent postoperative radiation therapy (50 patients) and 20 patients with history of previous radiotherapy Receives: Procedure: Prepectoral breast reconstruction with polyurethane implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
reconstruction failure
loss of implant or switch to autologus recosntruction
Measured: 12 months
major complications
evaluation of hematoma, infection, flap necrosis, wound dehiscence rate
Measured: 12months
minor complications
evaluation of seroma, rippling, casular contracture, asymmetry rate
Measured: 12 months
risk factor
evaluation of the risk factors correlated to recostruction failure
Measured: 12 months
Secondary outcomes (2)
postoperative radiation therapy on patients underwent prepectoral breast reconstruction with polyurethane implantes
evaluation if the post operative radiation therapy is correlated with an increase of reconstruction failure and capsular contracture
Measured: 12 months
patients previously irradiated (QUART) and underwent prepectoral breast reconstruction with polyurethane implantes
analysis of clinical characteristics of pre irradiatred patients submitted to prepectoral breast recosntruction with polyurethane implantes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start18 Mar 2020
- Primary completion22 Dec 2022
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prepectoral Breast ReconstructionStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 237 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, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216106
- Sponsor's protocol ID
- UID 4260
- Acronym
- IBR-PPBR
- Status last verified
- Sep 2023
- First submitted
- 21 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salgarello M, Pagliara D, Barone Adesi L, Visconti G, Wild JB, Matey P. Direct to Implant Breast Reconstruction With Prepectoral Micropolyurethane Foam-Coated Implant: Analysis of Patient Satisfaction. Clin Breast Cancer. 2021 Aug;21(4):e454-e461. doi: 10.1016/j.clbc.2021.01.015. Epub 2021 Jan 23.
PubMed 33627298de Vita R, Buccheri EM, Villanucci A, Pozzi M. Breast Reconstruction Actualized in Nipple-sparing Mastectomy and Direct-to-implant, Prepectoral Polyurethane Positioning: Early Experience and Preliminary Results. Clin Breast Cancer. 2019 Apr;19(2):e358-e363. doi: 10.1016/j.clbc.2018.12.015. Epub 2018 Dec 27.
PubMed 30691930
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepectoral Breast Reconstruction With Polyurethane Implantes and Radiotherapy: a Single Center Retrospective Study Evaluating Risk and Complications
- ClinicalTrials.gov ID
- NCT06216106
- Acronym / sponsor ID
- IBR-PPBR / UID 4260
- Keywords
- PPBR, POLYURETHANE, IBR, RADIOTHERAPY, BREAST IMPLANTS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 22 Jan 2024 (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 observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.
Detailed description
The study is a data collection of 250 patients for a total of 317 breasts underwent prepectoral breast recosntruction with polyurethane implantes. It is a retrospective study of a single center. The investigators gave indication to that type of reconstruction only to patients with good thickness (> 0.5 cm) and vascularity of skin flap after mastectomy.
The investigators used not selective criteria regarding risk factors so to better evaluate wich of them has a negative trend on the success of the reconstruction and on the major and minor complications. In that way the investigators tried to definde clarly the correct indications for this type of reconstruction.
In addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence.
The investigators decide to perform prepectoral breast reconstruction also in 20 patientes underwent previous radiotherapy dependig on the grade of cutaneus radiodistrophy, so to propose our less invasive approach to these patients normally candidates to autologus breast reconstruction
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergone prepectoral breast reconstruction | – | Procedure: Prepectoral breast reconstruction with polyurethane implantsAs the retrospective nature of this study, we have no exlusion criterias. We included all the patients with prepectoral breast reconstruction with polyurethane covered implants. We also included patients underwent postoperative radiation therapy (50 patients) and 20 patients with history of previous radiotherapy |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Patientes undergone immediate prepectoral breast reconstruction with polyurethane implantes
Key inclusion criteria (2 listed)
- patients underwent prepectoral breast recosntruction with polyurethane implants after skin or nipple sparing masectomy
- adequate mastectomy flap in vascularity and thickness
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Prepectoral breast reconstruction with polyurethane implantsBreast reconstruction in the prepectoral plane without elevate the pectoralis major muscle. We choose this type of reconstruction only in patients with mastectomy flap thickness of plus then 0.5 cm. We usally use silicone implants covered by an external layer of polyurethane so not to put directly in contact the silicone with the subcutaneus tissue. | Procedure or surgery | patients undergone prepectoral breast reconstruction |
Primary outcome
reconstruction failure
Time frame: 12 months
loss of implant or switch to autologus recosntruction
major complications
Time frame: 12months
evaluation of hematoma, infection, flap necrosis, wound dehiscence rate
minor complications
Time frame: 12 months
evaluation of seroma, rippling, casular contracture, asymmetry rate
risk factor
Time frame: 12 months
evaluation of the risk factors correlated to recostruction failure
2 secondary outcomes
postoperative radiation therapy on patients underwent prepectoral breast reconstruction with polyurethane implantes
Time frame: 12 months
patients previously irradiated (QUART) and underwent prepectoral breast reconstruction with polyurethane implantes
Time frame: 12 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 22 Jan 2024.
- Background: PubMed 33627298Salgarello M, Pagliara D, Barone Adesi L, Visconti G, Wild JB, Matey P. Direct to Implant Breast Reconstruction With Prepectoral Micropolyurethane Foam-Coated Implant: Analysis of Patient Satisfaction. Clin Breast Cancer. 2021 Aug;21(4):e454-e461. doi: 10.1016/j.clbc.2021.01.015. Epub 2021 Jan 23.
- Background: PubMed 30691930de Vita R, Buccheri EM, Villanucci A, Pozzi M. Breast Reconstruction Actualized in Nipple-sparing Mastectomy and Direct-to-implant, Prepectoral Polyurethane Positioning: Early Experience and Preliminary Results. Clin Breast Cancer. 2019 Apr;19(2):e358-e363. doi: 10.1016/j.clbc.2018.12.015. Epub 2018 Dec 27.
- Individual participant dataSharing planned: No
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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 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 Prepectoral Breast Reconstruction and Breast Reconstruction, 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 1 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 22 Jan 2024. 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?
reconstruction failure (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06216106, which also lists 2 linked publications.
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 22 Jan 2024.