Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patient satisfaction
- timeFrame
- 24 months of follow-up
- description
- 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 outcomes (1)
- measure
- Pain Evaluation
- timeFrame
- 24 months of follow-up
- description
- Pain will be assessed trough Visual Analogic Scale (from minimum 0 to maximum 10). Higher values mean worse outcome
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available