Clinical trial · Interventional
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
Return of Breast Sensation Following Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer: An Evaluation of Clinical, Sensory, and Quality of Life Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Research cancelled because of inadequate staffing.
Summary
Brief summary (as posted)
Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy. Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following 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 Reconstruction | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Breast Reconstruction | Procedure | — | UNRESOLVED |
| Breast Reconstruction with Artificial Implant | Procedure | — | UNRESOLVED |
| Neurotization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Breast Reconstruction with Artificial Implant
- description
- Participants undergoing unilateral reconstruction: patient will serve as internal control with contralateral breast and reconstructed breast will be compared to all other reconstructed breasts. Participants undergoing bilateral reconstruction: reconstructed breasts will be compared to all other reconstructed breasts
- interventionNames
- Procedure: Breast Reconstruction with Artificial Implant
- type
- ACTIVE_COMPARATOR
- label
- Autologous Breast Reconstruction without Neurotization
- description
- Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery
- interventionNames
- Procedure: Autologous Breast Reconstruction
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing unilateral or bilateral skin sparing mastectomy for breast cancer * Patient must have one of the following reconstructions in planned: * Immediate tissue expander placement * Immediate implant placement * Immediate autologous breast reconstruction * All patients participating in the study must be willing to be consented for enrollment at the pre-operative visit. Exclusion Criteria: * Pre-operative radiation therapy * Any pre-excising * Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"
References
Publications (0)
Data not yet available