Breast Reconstruction Following Mastectomy
Conditions
Brief summary
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with implant-based breast reconstruction. The main questions it aims to answer are: * Does nerve grafting improve objective breast sensation compared with reconstruction without nerve grafting? * Does nerve grafting improve patient-reported breast sensation? Researchers will compare the breast that receives the nerve graft with the breast that does not receive a nerve graft to determine whether nerve grafting improves sensory recovery. Participants will: * Undergo bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction as planned standard care. * Receive an allogeneic nerve graft (Avance Nerve Scaffold) on one breast, with the side receiving the graft determined randomly. * Have breast sensation measured using a light-touch test before surgery and at approximately 6, 12, and 24 months after surgery. * Complete questionnaires about breast sensation at the same time points.
Interventions
BIOLOGICALAllogeneic Nerve Grafting
A processed allogeneic nerve graft (Avance Nerve Scaffold) will be used to reconstruct the sensory nerve pathway during bilateral nipple-sparing mastectomy with immediate implant-based breast reconstruction. The breast receiving the nerve graft will be randomly assigned for each participant. The graft will be connected proximally to an identified intercostal nerve and, when an appropriate distal nerve target is identified, connected to the nerve supplying the nipple-areolar complex. When no distal nerve target is identified, the distal graft will be secured to the dermis beneath the nipple. The contralateral breast will undergo the planned implant-based reconstruction without nerve grafting and will serve as the within-subject control.
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
All participants will receive the same intervention, with the side receiving the nerve graft randomly assigned within each participant. The contralateral breast will serve as the control.
Eligibility
Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subjects greater or equal to 22 years of age. * Subject is considered a candidate for nipple sparing mastectomy by the breast and plastic surgeon * First-time breast reconstruction post-mastectomy for target breasts. * Subject is planning to undergo bilateral nipple-sparing mastectomy with immediate, implant-based, subpectoral or prepectoral breast reconstruction. * Mastectomy performed to address ductal carcinoma-in-situ (DCIS) or for cancer prophylaxis. * An informed consent form is signed by subject * Subject is capable of following protocol procedures and complying with follow-up visit requirements.
Exclusion criteria
* Subject has undergone prior radiation therapy to the reconstruction site or chest wall. * Subject has a BMI \> 35. * Subject has a known diagnosis of diabetes with a HbA1c \> 7.0mmol/L within 30 days of the mastectomy * Subject is a tobacco/nicotine user within 30 days prior to Index Surgery. * Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction. * Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up. * Subject is currently participating or planning to participate in another investigational drug, biologic, or medical device study that may interfere with compliance of this study requirements or may confound this study data/outcomes. * Subject is pregnant or lactating at the time of the mastectomy. * If the patient has a diagnosis of DCIS, there no radiographic evidence of DCIS within 1 cm of the skin or nipple or foci suspicious for microinvasion. * Patients with a diagnosis of grade III DCIS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Sensation Measured by Semmes-Weinstein Monofilament Testing | Baseline, 6 months, 12 months, and 24 months after surgery | Breast sensation will be objectively assessed using Semmes-Weinstein monofilament testing on the breast receiving the nerve graft and the contralateral non-grafted breast. Sensory measurements will be compared between the grafted and non-grafted breasts to evaluate the effect of allogeneic nerve grafting on sensory recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Breast Sensation | Baseline, 6 months, 12 months, and 24 months after surgery | Patient-reported breast sensation will be assessed using questionnaires. Scores will be compared between the grafted and non-grafted breasts to evaluate whether allogeneic nerve grafting improves patients' perception of breast sensation. |
Countries
United States
Contacts
CONTACTGrace K Jukovich, MPH
CONTACTMark Sisco, MD, FACS
PRINCIPAL_INVESTIGATORMark Sisco, MD, FACS
Endeavor Health
Outcome results
None listed