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

Sensitisation Clinical Trial

Official title:

DIEP Flap Sensory Recovery Following Direct Neurotization in Breast Reconstruction - A Blinded Prospective Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04818190
• Other study ID #: HS24687
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sensitisation

Intervention

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.

Locations

Country	Name	City	State
Canada	Health Science Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory recovery to neurotized DIEP flap	Sensory recovery measured using Pressure Specified Sensory Device	3 months post-operatively
Primary	Sensory recovery to neurotized DIEP flap	Sensory recovery measured using Pressure Specified Sensory Device	6 months post-operatively
Primary	Sensory recovery to neurotized DIEP flap	Sensory recovery measured using Pressure Specified Sensory Device	12 months post-operatively