Using tissue expanders and acellular dermal matrix for breast reconstruction after mastectomy
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
This study is testing a new method for breast reconstruction after mastectomy using tissue expanders and a special material to see how well it works for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Sex | Female |
| Sponsor | University of Bari Academic / other |
| Locations | 1 site (Bari, BA) |
| Trial ID | NCT06374628 on ClinicalTrials.gov |
What this trial studies
This research evaluates the clinical outcomes of a two-stage muscle-sparing breast reconstruction technique that utilizes a tissue expander completely covered by acellular dermal matrix (ADM). The study aims to report on surgical indications, provide technical tips, and assess both clinical and histological outcomes. Ultimately, the goal is to develop a decision-making algorithm to guide immediate prosthetic breast reconstruction following mastectomy. This observational study focuses on patients who have undergone unilateral or bilateral mastectomy and are considering this reconstruction method.
Who should consider this trial
Good fit: Ideal candidates include women who have undergone unilateral or bilateral mastectomy and are seeking two-stage breast reconstruction using a tissue expander and ADM.
Not a fit: Patients who have had previous breast surgery or those requiring submuscular tissue expander placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and patient satisfaction in breast reconstruction after mastectomy.
How similar studies have performed: While this approach is innovative, similar studies have shown promising outcomes in muscle-sparing techniques for breast reconstruction.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bari, BA
- AOU Policlinico — Bari, Ba, Italy (Recruiting)
Study contacts
- Study coordinator: rossella elia
- Email: rossellaelia4@gmail.com
- Phone: +393409616476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.