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

NCT04818190 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-10-04

No results posted yet for this study

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.

Conditions

  • Sensitisation

Interventions

PROCEDURE

Sensory neurotization

The donor nerve is a cutaneous nerve that is identified with the most inferior lateral perforator vessels. The nerve is then dissected for neurotization and divided at the level of the fascia where it is a pure sensory nerve. The recipient intercostal nerve is usually easily identified in the third intercostal space during the dissection of the internal mammary artery and vein. The anterior branch of the third intercostal nerve can usually be found at the junction of the inferior portion of the third rib and the sternum, approximately 80% of the time. The nerve is dissected and transected medially. It is then mobilized to give it the longest length possible in preparation for neurotization. Neurotization is performed by coapting the donor nerve to the third anterior intercostal nerve directly with a 9-0 nylon suture in standard fashion.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Rebecca Miller, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-04-01
Completion
2023-05-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04818190 on ClinicalTrials.gov