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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06374628

Enrollment

Registered

2024-04-18

Start date

2019-06-01

Completion date

2024-12-31

Last updated

2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

PROCEDUREbreast reconstruction

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
Patient satisfaction	24 months of follow-up	Patients satisfaction will be evaluated through BREAST-Q questionnaire. the results from the questionnaire will be converted into a 0-100 scale with higher values meaning a better outcome

Secondary

Measure	Time frame	Description
Pain Evaluation	24 months of follow-up	Pain will be assessed trough Visual Analogic Scale (from minimum 0 to maximum 10). Higher values mean worse outcome

Other

Measure	Time frame	Description
Complication rate	24 months of follow-up	Complication will be recorded and classified with Clavien-Dindo Classification

Countries

Italy

Contacts

Primary Contactrossella elia

rossellaelia4@gmail.com+393409616476

Backup Contactmichele maruccia

marucciam@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026