Clinical trial · Interventional
Pre-pectoral Breast Reconstruction PART 2
Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in Pre-pectoral Implant Based Breast Reconstruction
- 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 rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Two-stage with Acellular Dermal Matrix (CELLIS® Breast) | Device | — | UNRESOLVED |
| Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ADM two-stage reconstruction
- description
- Two-stage with Acellular Dermal Matrix (CELLIS® Breast). Tissue Expander A, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by ADM
- interventionNames
- Device: Two-stage with Acellular Dermal Matrix (CELLIS® Breast)
- type
- EXPERIMENTAL
- label
- TCPM two-stage reconstruction
- description
- Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra). Tissue Expander B, Pre-pectoral, subcutaneous, two-stage reconstruction by means of TE supported by TCPM
- interventionNames
- Device: Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM, nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM), both prophylactic and therapeutic. Included patients baseline characteristics will be: * age 18-80 years old * BMI between 18.5 and 35. * Former smokers (up until 3 weeks before surgery) * hypertension at oral medications * diabetes * previous breast surgery * previous breast and chest wall radiation therapy will be allowed. Exclusion Criteria: * T4 and metastatic breast cancers * obese patients (BMI over 35) * currently smoking patients (within 3 weeks before surgery) * refusal to sign the consent * severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).
References
Publications (0)
Data not yet available