Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction
Recruiting
- Conditions
- Breast Cancer
- Registration Number
- NCT06374628
- Lead Sponsor
- Rossella Elia, MD PhD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 44
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
AOU Policlinico
🇮🇹Bari, BA, Italy