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

NCT04818190 | Unknown

• 1 other identifier: HS24687
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensitisation

Keywords

breast reconstruction; sensory recovery; DIEP reconstruction

Outcome Measures

Primary Outcomes (3)

• Sensory recovery to neurotized DIEP flap

  Sensory recovery measured using Pressure Specified Sensory Device

  3 months post-operatively

• Sensory recovery to neurotized DIEP flap

  Sensory recovery measured using Pressure Specified Sensory Device

  6 months post-operatively

• Sensory recovery to neurotized DIEP flap

  Sensory recovery measured using Pressure Specified Sensory Device

  12 months post-operatively

Study Arms (2)

DIEP reconstruction, no neurotization

NO INTERVENTION

DIEP reconstruction No sensory neurotization

DIEP reconstruction, neurotization

EXPERIMENTAL

DIEP reconstruction With sensory neurotization

Procedure: Sensory neurotization

Interventions

Sensory neurotization PROCEDURE

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.

DIEP reconstruction, neurotization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Science Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Study Officials

• Rebecca Miller, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 26, 2021
• Study Start: September 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)