Breast CancerNCT06374628
Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction
An observational study of Breast Cancer, run by Rossella Elia, MD PhD at 1 site in Italy.
Trial summary
The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 31 Dec 2024
- 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: consecutive patients who undergo two stage breast recontrustion with tissue expander and ADM
Who may be able to join
- unilateral or bilateral mastectomy followed by two stage breast reconstruction with subcutaneous tissue expander and Acellular Dermal Matrix (ADM)
- risk-reducing mastectomies followed by two stage breast reconstruction with subcutaneous tissue expander and ADM
Who cannot join
- partial or total submuscular tissue expander placement,
- tissue expander placement in conjunction with latissimus dorsi muscle flap or without ADM, -delayed reconstructions
- previous breast surgery
Trial locations and contacts
1 site in 1 country.
michele maruccia contact
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico
Bari, BA
Rossella Elia, 3409616476, rossellaelia4@gmail.com
About this study
Official title: Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction: Indications, Surgical Technique and Clinical Outcomes With Histological and Ultrasound Follow-up
The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction.
- Conditions
- Breast Cancer
- Being tested
- breast reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast reconstructionProcedure or surgery
breast reconstruction in two-stages using tissue expander entirely wrapped by acellular dermal matrix
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patients satisfaction will be evaluated through BREAST-Q questionnaire. the results from the questionnaire will be converted into a 0-100 scale with higher values meaning a better outcome
Measured: 24 months of follow-up
Secondary outcomes (1)
Pain Evaluation
Pain will be assessed trough Visual Analogic Scale (from minimum 0 to maximum 10). Higher values mean worse outcome
Measured: 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jun 2019
- Primary completion1 Apr 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rossella Elia, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rossella Elia, MD PhD, University of Bari
- Investigators
- Giuseppe Giudice, Study director, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374628
- Sponsor's protocol ID
- 0001
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction: Indications, Surgical Technique and Clinical Outcomes With Histological and Ultrasound Follow-up
- ClinicalTrials.gov ID
- NCT06374628
- Acronym / sponsor ID
- 0001
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Rossella Elia, MD PhDUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 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 aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients who undergo two stage breast recontrustion with tissue expander and ADM
Key inclusion criteria (2 listed)
- unilateral or bilateral mastectomy followed by two stage breast reconstruction with subcutaneous tissue expander and Acellular Dermal Matrix (ADM)
- risk-reducing mastectomies followed by two stage breast reconstruction with subcutaneous tissue expander and ADM
Key exclusion criteria (3 listed)
- partial or total submuscular tissue expander placement,
- tissue expander placement in conjunction with latissimus dorsi muscle flap or without ADM, -delayed reconstructions
- previous breast surgery
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 |
|---|---|---|
| breast reconstructionbreast reconstruction in two-stages using tissue expander entirely wrapped by acellular dermal matrix | Procedure or surgery | – |
Primary outcome
Patient satisfaction
Time frame: 24 months of follow-up
Patients satisfaction will be evaluated through BREAST-Q questionnaire. the results from the questionnaire will be converted into a 0-100 scale with higher values meaning a better outcome
1 secondary outcome
Pain Evaluation
Time frame: 24 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
michele maruccia contact
Giuseppe Giudice study director
University of Bari
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 Cancer, run by Rossella Elia, MD PhD 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: status not confirmed, as of the sponsor's last update on 18 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rossella elia (+393409616476, rossellaelia4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 24 months of follow-up). 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 18 Apr 2024.