DIEP Flap Sensory Recovery Following Direct Neurotization in Breast Reconstruction - A Blinded Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Manitoba
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Sensory recovery to neurotized DIEP flap
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DIEP reconstruction, no neurotization
DIEP reconstruction No sensory neurotization
DIEP reconstruction, neurotization
DIEP reconstruction With sensory neurotization
Intervention: Sensory neurotization (Procedure)
Outcomes
Primary Outcomes
Sensory recovery to neurotized DIEP flap
Time Frame: 12 months post-operatively
Sensory recovery measured using Pressure Specified Sensory Device
Sensory recovery to neurotized DIEP flap
Time Frame: 3 months post-operatively
Sensory recovery measured using Pressure Specified Sensory Device
Sensory recovery to neurotized DIEP flap
Time Frame: 6 months post-operatively
Sensory recovery measured using Pressure Specified Sensory Device
Secondary Outcomes
No secondary outcomes reported