Clinical trial NCT04818190: DIEP (Deep Inferior Epigastric Artery Perforator) Flap Sensory Recovery Following Neurotization
Official title: DIEP Flap Sensory Recovery Following Direct Neurotization in Breast Reconstruction - A Blinded Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sensitisation
Keywords: breast reconstruction
sensory recovery
DIEP reconstruction
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the sensory return of DIEP flaps with nerve connection to DIEP flaps with no nerve connection to see which is better.

This research is being done because the presence of sensation in a reconstructed breast has been shown to improve patient-related quality of life following mastectomy reconstruction and is an important safety factor for prevention of burns and other flap injuries. Unfortunately, women who have breast skin excised during mastectomy are reconstructed with a traditional DIEP flap that does not restore sensation to the skin.

Detailed description: The Deep Inferior Epigastric Perforator (DIEP) flap is the current standard of care in breast reconstruction. The DIEP flap does not normally have sensation restored. The presence of sensation in a reconstructed breast has been shown to improve patient-rated quality of life following mastectomy and reconstruction and is an important safety factor for prevention of burns and other flap injuries. Unfortunately, women who have breast skin excised during mastectomy are reconstructed with a traditional DIEP flap that does not restore sensation to the skin. As such, the investigators aim to perform a prospective randomized single-blinded trial to evaluate sensory return to DIEP flaps following nerve coaptation.

A blinded, prospective study will be performed involving Manitoban women over 18 years undergoing bilateral breast reconstruction with DIEP flaps. The women will have one breast reconstructed in the standard of care (DIEP flap with no nerve coaptation) and one breast reconstructed with both DIEP flap and sensory nerve coaptation; the side of coaptation will be randomized. Objective sensibility to the breast will be tested pre- and post-operatively (3, 6, 12 months) using the Pressure Specified Sensory Device (PSSD). Patients will also complete the Breast Q questionnaire postoperatively.

Eligibility criteria: Inclusion Criteria:

* female subjects older than 18
* scheduled for immediate bilateral breast reconstruction following bilateral non-nipple sparing mastectomy
* using DIEP free flap reconstruction
* with a large skin paddle

Exclusion Criteria:

* pre-operative radiation or chemotherapy was performed
* post-operative radiation or chemotherapy is planned
* reconstruction is performed in a delayed fashion
* a nerve conduit is necessary for nerve coaptation

Primary outcomes:
measure: Sensory recovery to neurotized DIEP flap
timeFrame: 3 months post-operatively
measure: Sensory recovery to neurotized DIEP flap
timeFrame: 6 months post-operatively
measure: Sensory recovery to neurotized DIEP flap
timeFrame: 12 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Science Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Rebecca Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: