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

NCT06374628 | Recruiting

• 1 other identifier: 0001
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Evaluation

  24 months of follow-up

Other Outcomes (1)

• Complication rate

  24 months of follow-up

Interventions

breast reconstruction PROCEDURE

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rossella Elia, MD PhD: lead

Study Sites (1)

AOU Policlinico

Bari, BA, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Giuseppe Giudice

  University of Bari

  STUDY DIRECTOR

Central Study Contacts

rossella elia

CONTACT

+393409616476; rossellaelia4@gmail.com

michele maruccia

CONTACT

marucciam@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full time researcher, Unit of Plastic and Reconstructive Surgery, Policlinico of Bari

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 18, 2024
• Study Start: June 1, 2019
• Primary Completion: April 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

IT (1)