Split Chest Breast Neurotization (NCT05757778) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Split Chest Breast Neurotization
United States6 participantsStarted 2023-08-08
Plain-language summary
Several members of the scientific community have suggested that breast neurotization can help return nipple sensation to patients undergoing implant-based breast reconstruction. There has been no randomized controlled study assessing the validity of these claims. The goal of this study is to evaluate if performing breast neurotization can help restore or improve return of nipple sensation to patients undergoing implant-based breast reconstruction. This will be a single-blinded, randomized controlled trial where patients undergoing bilateral reconstruction will serve as their own controls by receiving an intervention on one breast but not the other breast.
Who can participate
Age range
18 Years – 99 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women undergoing bilateral nipple-sparing mastectomy (prophylactic or therapeutic) at a single institution
* Women receiving implant-based reconstruction (either direct to implant or tissue expander-based implant reconstruction of any size)
* Age 18 or older
Exclusion Criteria:
* Women with history of prior breast surgery given concern for potentially damaged nerves by prior intervention that could impact the procedure and results. Procedures include but are not limited to: prior breast reduction, prior breast augmentation, prior lumpectomy
* Pre-operative radiation or anticipated post-operative radiation
* Body Mass Index (BMI) \> 30 kg/m2 or patients with macromastia (larger breasts) as these patients frequently require larger implants that will not accommodate the longest nerve graft available (70 mm)
* Current tobacco or nicotine use
* History of diabetes mellites with a HgbA1c \> 7% due to lower rates of wound healing
* History of auto-immune disease
* History of allergy, sensitivity, or intolerance to porcine-derived materials
* Intraoperatively, patients may have to be excluded if during the mastectomy the lateral nerve targets were severely damaged or removed as part of the mastectomy. While these patients will be excluded from the formal analysis, the investigators will continue to follow them as a subgroup for analysis and comparison.
* Men as they infrequently receive bilateral mastectomies due to breast cancer. Male breast cancer is \<1% o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Semmes-Weinstein Monofilament Testing (SWMT) Score in the Nipple (Area 9)