Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction

NCT ID: NCT06374628

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

breast reconstruction

breast reconstruction in two-stages using tissue expander entirely wrapped by acellular dermal matrix

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rossella Elia, MD PhD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rossella Elia, MD PhD

Full time researcher, Unit of Plastic and Reconstructive Surgery, Policlinico of Bari

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giuseppe Giudice

Role: STUDY_DIRECTOR

University of Bari

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOU Policlinico

Bari, BA, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

rossella elia

Role: CONTACT

+393409616476

michele maruccia

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rossella Elia

Role: primary

3409616476

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.