Clinical trial · Interventional
Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer
Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer: Randomized Clinical Trial
NCT04092842CI-TRIAL-00057606PROSILMAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 placement of a small silicone prosthesis in the partial defects generated by conservative breast cancer surgery improves the aesthetic result, compared to the usual surgical technique, in a safe and reproducible way and compatible with adjuvant treatments. It could also potentially improve the quality of life of patients
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 Conserving Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Silicone prosthesis | Device | — | UNRESOLVED |
| Usual practice | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group intervention: Silicone prothesis
- description
- Breast cancer conservative surgery will be performed by removing the tumor according to the usual technique and then the defect generated will be filled with a silicone prosthesis of the same size. Said prosthesis will be covered with fat and subcutaneous cellular tissue and then the skin will be closed.
- interventionNames
- Device: Silicone prosthesis
- type
- ACTIVE_COMPARATOR
- label
- Group control: Usual surgical technique
- description
- Breast cancer conservative surgery will be performed according to the usual surgical technique, that is, removing the tumor and covering the defect by mobilizing the breast tissue and then closing the skin.
- interventionNames
- Procedure: Usual practice
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Women, over 18 years old, with breast cancer who attend breast pathology consultations at the Sant Pau Hospital in which conservative surgery is indicated. Exclusion Criteria: * Multicentric tumors * Tumors larger than 5cm * Locally advanced tumors (T4): Deep plane involvement or skin involvement * Patients in stages IV (distance dissemination) * Patients who need mastectomy * Patients with disabilities or who do not understand the terms of the study or do not agree to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.