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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: breast reconstruction

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: rossella elia; Phone Number: +393409616476; Email: rossellaelia4@gmail.com
• Study Contact Backup: Name: michele maruccia; Email: marucciam@gmail.com

Study Locations

• Italy
  • BA
    • Bari, BA, Italy
      • Recruiting
      • AOU Policlinico
      • Contact: Rossella Elia; Phone Number: 3409616476; Email: rossellaelia4@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

consecutive patients who undergo two stage breast recontrustion with tissue expander and ADM

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	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	24 months of follow-up

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rossella Elia, MD PhD
• Investigators: Study Director: Giuseppe Giudice, University of Bari

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 0001 (Researcher)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No