Clinical trial · Interventional
Pre-pectoral Breast Reconstruction PART 1
Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in DIRECT-TO-IMPLANT (DTI) 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 |
|---|---|---|---|
| DTI with Acellular Dermal Matrix (CELLIS® Breast) | Device | — | UNRESOLVED |
| DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Direct-To-Implant A
- description
- DTI with Acellular Dermal Matrix (CELLIS® Breast), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of an Acelluar Dermal Matrix (ADM)
- interventionNames
- Device: DTI with Acellular Dermal Matrix (CELLIS® Breast)
- type
- EXPERIMENTAL
- label
- Direct-To-Implant B
- description
- DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra), pre-pectoral, subcutaneous direct-to-implant breast reconstruction with the aid of a titanium coated polypropylene mesh
- interventionNames
- Device: DTI 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) * 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