Clinical trial NCT04533373: Sensory Restoration After DIEP Flap Neurotization
Official title: The Effect of DIEP Flap Neurotization on Sensory Restoration After Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Breast Reconstruction
Sensory Restoration
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Axogen Corporation
First posted: 2020-08-31
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Common goals of breast reconstruction include obtaining satisfactory breast symmetry, softness, and appropriate size and shape. Advances in surgical techniques have prompted a new goal: achieving breast sensation after reconstructive surgery. This desire has led the surgical community to investigate operative techniques for achieving this goal. However, few studies have examined the effectiveness of breast sensory restoration.

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 case, the investigators want to restore function of the nerves that supply the skin overlying the breast(s).

The investigators will be performing breast reconstruction using tissue from the patient's abdomen and transferring it to the chest wall to repair the mastectomy defect. Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue (i.e the new "source") that is being transferred and attaching it to a nerve in the chest wall.

The Avance® Nerve graft is a nerve graft material that has been produced by Axogen, Inc. The graft is made by processing donated human nerves. This graft is used during neurotization to bridge the gap and join the nerve from the abdominal tissue to the nerve in the chest wall. The use of the graft helps the body to attach these 2 nerves and improves nerve repair.

When neurotization is done without the nerve graft there is a possibility that the surgeon may require extra nerve material to join the 2 nerves. Traditionally, in this case the surgeon would have to obtain a separate donor nerve from another part of the patient's body. This technique carries the risk of complications to part of the body that the separate donor nerve was obtained from - loss of sensation, infection or neuroma formation (an abnormal growth of nerve tissue that can cause pain, burning or tingling sensation, numbness). The Avance nerve graft avoids the need for the additional donor nerve and the possible complications associated with it.

The Avance® Nerve Graft is currently being used in some women during breast reconstruction surgery, however the effectiveness of this procedure in improving the restoration of sensation has not been proven.

Women undergoing reconstruction of one breast and at the same time using the women's own tissue as part of standard clinical care, may join.


Eligibility criteria: Inclusion Criteria:

1. All patients presenting to Johns Hopkins who have had or will have mastectomy (therapeutic or prophylactic) and are planning to undergo unilateral mastectomy followed by breast reconstruction with autologous deep inferior epigastric perforator flap (DIEP) will be included.

   These patients will then be randomized in either of two treatment modalities:
   * Treatment Modality 1: Breast reconstruction with DIEP flap and neurotization.
   * Treatment Modality 2: Breast reconstruction with DIEP flap but without neurotization.
2. 18 years of age and older
3. The patient is aware of the nature of her malignancy if a malignancy has been diagnosed; understands the study purpose, requirements, and risks; and is able and willing to sign an informed consent.

Exclusion Criteria:

1. Autologous reconstruction where the flap is buried.
2. Exclusion criteria will encompass any patient with: diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications.
3. Pregnant or lactating women will be excluded from this study.
4. Women with recurrent breast cancer will be excluded.
5. Women with previous reconstructive procedures or who have previously undergone lumpectomy with radiation will be excluded.

Primary outcomes:
measure: 12-month Breast sensation as assessed by the AcroValTM device
timeFrame: 12-months after DIEP Flap neurotization
Secondary outcomes:
measure: Breast sensation at 6 months as assessed by the AcroValTM device
timeFrame: 6 months after DIEP flap breast reconstruction
measure: Breast sensation at 18 months as assessed by the AcroValTM device
timeFrame: 18 months after DIEP flap breast reconstruction
measure: Breast sensation at 24 months as assessed by the AcroValTM device
timeFrame: 24 months after DIEP flap breast reconstruction
measure: Breast-specific health-related quality of life using the Breast-Q®
timeFrame: 6 months after DIEP flap breast reconstruction
measure: Breast-specific health-related quality of life using the Breast-Q®
timeFrame: 12 months after DIEP flap breast reconstruction
measure: Breast-specific health-related quality of life using the Breast-Q®
timeFrame: 18 months after DIEP flap breast reconstruction
measure: Breast-specific health-related quality of life using the Breast-Q®
timeFrame: 24 months after DIEP flap breast reconstruction
measure: General health-related quality of life using the SF-12
timeFrame: 6 months after DIEP flap breast reconstruction
measure: General health-related quality of life using the SF-12
timeFrame: 12 months after DIEP flap breast reconstruction
measure: General health-related quality of life using the SF-12
timeFrame: 18 months after DIEP flap breast reconstruction
measure: General health-related quality of life using the SF-12
timeFrame: 24 months after DIEP flap breast reconstruction
measure: Change in breast sensation as assessed by the AcroValTM device
timeFrame: Baseline, 6, 12, 18 and 24 months after DIEP flap breast reconstruction
measure: Change in breast-specific health-related quality of life using the Breast-Q®
timeFrame: Baseline, 6, 12, 18, and 24 months after DIEP flap breast reconstruction
measure: Change in general health-related quality of life using the SF-12
timeFrame: Baseline, 6, 12, 18, and 24 months after DIEP flap breast reconstruction
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gedge D Rosson, MD
role: PRINCIPAL_INVESTIGATOR
References: