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

R

Rossella Elia, MD PhD

Status

Enrolling

Conditions

Breast Cancer

Treatments

Procedure: breast reconstruction

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

michele maruccia; rossella elia

Data sourced from clinicaltrials.gov

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