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

RECRUITINGSponsored by Rossella Elia, MD PhD
Actively Recruiting
SponsorRossella Elia, MD PhD
Started2019-06-01
Est. completion2024-04-01
Eligibility
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06374628

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: FEMALEHealthy volunteers 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

Conditions2

Breast CancerCancer

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