RecruitingNCT06374628

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

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


Sponsor

Rossella Elia, MD PhD

Enrollment

44 participants

Start Date

Jun 1, 2019

Study Type

OBSERVATIONAL

Conditions

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 decision-making algorithm for immediate prosthetic breast reconstruction.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is collecting safety and outcome data on a modern breast reconstruction technique called pre-pectoral (above the muscle) reconstruction using a tissue expander and acellular dermal matrix (ADM — a biological mesh). It is used after mastectomy and avoids the older method of placing the expander under the chest muscle. **You may be eligible if...** - You had a mastectomy (single or double) followed by two-stage reconstruction using a tissue expander placed above the chest muscle (pre-pectoral), with ADM support - You had a preventive (risk-reducing) mastectomy with the same reconstruction approach **You may NOT be eligible if...** - Your expander was placed under the muscle (submuscular) - Your reconstruction used a back muscle flap (latissimus dorsi) or did not use ADM - You had a delayed reconstruction (not at the same time as mastectomy) - You have had prior breast surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREbreast reconstruction

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


Locations(1)

AOU Policlinico

Bari, BA, Italy

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NCT06374628


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