Clinical trial · Observational
Influencing Factors and Mechanisms of Capsular Contracture After Prosthesis Reconstruction in Patients With Breast Cancer
NCT07419971CI-TRIAL-00105699enrolling by invitationClinicalTrials.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 aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery.
Conditions
Conditions (2)
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 Females | — | UNRESOLVED | — |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| synthetic mesh | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Mesh
- description
- implant- based breast reconstruction with synthetic mesh
- interventionNames
- Procedure: synthetic mesh
- label
- Without Mesh
- description
- implant- based breast reconstruction without synthetic mesh
Primary outcomes (1)
- measure
- Aesthetic Outcome
- timeFrame
- From enrollment to the end of follow up at 6 months
- description
- Half a year post-IBBR, patients underwent a structured interview and physical examination by two independent senior breast surgeon, blinded to the surgical details, during outpatient visits using the Ueda Aesthetic Scale, "Excellent'" (9-10 points), ''Good'' (7-8points), ''Fair'' (5-6 points) and ''Poor'' (0-4 points).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Female adults aged 18 years or older; Undergoing mastectomy for breast cancer or prophylactic reasons; Receiving immediate implant-based reconstruction (either implant-only or combined with an autologous flap) Exclusion Criteria: Delayed reconstruction; Purely autologous reconstruction (without an implant); Incomplete postoperative follow-up data precluding effective aesthetic assessment
References
Publications (0)
Data not yet available
No reference posted for this study.