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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374628
• Other study ID #: 0001
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Bari
• Contact: rossella elia
• Phone: +393409616476
• Email: rossellaelia4[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Italy	AOU Policlinico	Bari	BA

Sponsors (1)

Lead Sponsor	Collaborator
Rossella Elia, MD PhD

Country where clinical trial is conducted

Italy, 

Outcome

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