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

Inclusion Criteria2

  • 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 Criteria3

  • 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

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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