This phase III trial compares DIEP flap neurotization to DIEP flap with no neurotization on sensory restoration after breast reconstruction. Sensory nerves are nerves responsible for sensation from skin. When a sensory nerve is cut, sensation is lost to the area supplied by the nerve. In the case of breast reconstruction this involves the nerves supplying the skin overlying breast(s). Neurotization refers to regeneration of the nerve after it has been cut. This means that the cut nerve is being repaired in order to restore its function. In neurotization this repair is carried out using a new “source”. In this trial, doctors want to restore function of the nerves that supply the skin overlying the breast(s). DIEP flap neurotization may improve breast sensation recovery after breast reconstruction.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04533373.
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of deep inferior epigastric perforators (DIEP) flap neurotization in improving breast sensation recovery, as measured using AcroVal, at 18 months after breast reconstruction among women undergoing unilateral DIEP flap breast reconstruction.
SECONDARY OBJECTIVES:
I. To evaluate the safety of DIEP flap neurotization in breast reconstruction, added operative time, length of stay and related complications.
II. To evaluate the efficacy of DIEP flap neurotization in improving breast sensation recovery, as measured using AcroVal, at 3, 6, 12, 24 months (2 years), and 48 months (4 years) after breast reconstruction among women undergoing unilateral DIEP flap breast reconstruction.
III. To evaluate the effect of DIEP flap neurotization on pain, patient-reported quality of life and patient satisfaction, at 3, 6, 12, 18, 24 months (2 years), and 48 months (4 years) after breast reconstruction among women undergoing unilateral DIEP flap breast reconstruction.
TERTIARY (EXPLORATORY) OBJECTIVES:
I. To evaluate return to sensation over time among women undergoing DIEP flap breast reconstruction.
II. To estimate the association between breast sensation and patient-reported quality of life outcomes and patient satisfaction.
III. To identify potential factors that influence results of breast reinnervation among women undergoing DIEP flap breast reconstruction (e.g., radiation, nipple-sparing versus total mastectomy).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo neurotization with Avance nerve graft during standard of care DIEP flap breast reconstruction.
ARM II: Patients undergo standard of care DIEP flap breast reconstruction.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorGedge Rosson
