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Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery. Standard breast reconstruction protocols typically do not address damaged intercostal nerves, leaving patients at risk for persistent nerve-related pain.
Prophylactic nerve surgery techniques, such as Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interfaces (RPNI), offer innovative approaches to prevent neuroma formation by managing damaged nerves during surgery. This study will evaluate whether incorporating prophylactic nerve surgery during second-stage implant exchange after tissue expander based breast reconstruction can reduce the incidence of PMPS compared to standard medical therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy). |
|
| Nerve Surgery | Experimental | Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve Surgery | Procedure | Patients undergoing prophylactic nerve surgery (RPNI) during second-stage implant exchange after tissue expander based breast reconstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-Mastectomy Pain Syndrome | Incidence of PMPS, defined as persistent pain beyond 6 months postoperatively. | Pre-operative visit (baseline) to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Breast Cancer Pain Questionnaire | Pain severity scores at 3, 6, and 12 months. | Pre-operative visit (baseline) to 12 months. |
| Adverse event rates | Complication and adverse event rates. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grace Wells, BS | Contact | 732-741-0970 | 1889 | gwells@sycamoremm.com |
| Name | Affiliation | Role |
|---|---|---|
| Kari Colen, MD | Advanced Reconstructive Surgery Alliance | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care (Investigator Choice) | Other | Patients receiving standard medical therapies for PMPS prevention (e.g., pharmacologic pain management, physical therapy). |
|
| Pre-operative visit (baseline) to 12 months. |
| D017437 |
| Skin and Connective Tissue Diseases |