Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT04818190 |
Other study ID # |
HS24687 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2021 |
Est. completion date |
May 1, 2023 |
Study information
Verified date |
March 2021 |
Source |
University of Manitoba |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.