UnknownNot Applicable

DIEP (Deep Inferior Epigastric Artery Perforator) Flap Sensory Recovery Following Neurotization

Canada30 participantsStarted 2021-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sensory recovery to neurotized DIEP flap

Timeframe: 3 months post-operatively

Sensory recovery to neurotized DIEP flap

Timeframe: 6 months post-operatively

Sensory recovery to neurotized DIEP flap

Timeframe: 12 months post-operatively

Trial details

NCT IDNCT04818190

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-01

View on ClinicalTrials.gov More Sensitisation trials