Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age22+
SponsorEndeavor Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Allogeneic Nerve Grafting
Biological/VaccineA 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.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Allogeneic Nerve GraftingExperimental treatment 1 intervention
Group B: No Nerve GraftingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Breast Sensation Measured by Semmes-Weinstein Monofilament Testing
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.
Time frame
Baseline, 6 months, 12 months, and 24 months after surgerySecondary outcomes
1
Patient-Reported Breast Sensation
Patient-reported breast sensation will be assessed using a study-specific questionnaire incorporating questions from the BREAST-Q Reconstruction Module. Each sensation item is scored on a 5-point Likert-type scale ranging from 1 (no feeling) to 5 (complete feeling), with higher scores indicating better breast sensation. Scores will be compared between the grafted and non-grafted breasts to evaluate whether allogeneic nerve grafting improves patients' perception of breast sensation.
Time frame
Baseline, 6 months, 12 months, and 24 months after surgeryOther outcomes
1
Neurotization-Related Complications
The occurrence of complications plausibly related to the nerve grafting procedure will be assessed, including neuropathic pain and neuroma formation.
Time frame
From surgery through 24 months after surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: