Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction

Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Sensory nerve coaptation

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

In this prospective study, patients who underwent an innervated or noninnervated DIEP flap breast reconstruction between August 2016 and August 2018 at Maastricht University Medical Center in the Netherlands were included if they returned for follow-up between August 2016 and August 2019.

Description

Inclusion Criteria:

• Female patients 18 years or older
• Unilateral or bilateral DIEP flap breast reconstruction
• Returned for follow-up between August 2016 and August 2019
• Informed consent

Exclusion Criteria:

• Total flap loss complication
• Flaps that required a take-back
• Follow-up less than six months postoperatively
• Only one postoperative measurement at less than 12 months follow-up
• Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Innervated DIEP flaps; Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction with additional sensory nerve coaptation.	Procedure: Sensory nerve coaptation; A recipient sensory nerve branch of the 11th-12th intercostal nerve was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.; Other Names: Neurotization; Neurorrhaphy; Reinnervation
Noninnervated DIEP flaps; Patients in this group underwent immediate or delayed, unilateral or bilateral DIEP flap breast reconstruction without sensory nerve coaptation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean monofilament value as a measure for the sensory recovery of the reconstructed breast	The sensory recovery of the breast to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Nine areas of the breast, indicating native skin and flap skin, were tested. Mean monofilament values were calculated for each area and compared between groups.	Through study completion up to 36 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean monofilament value as a measure for the sensory recovery of the reconstructed breast	The sensory recovery of the donor site to touch was tested at different follow-up moments after the initial surgery. Semmes-Weinstein monofilaments were used for sensory testing. Four areas of the donor site were tested, two areas above and two areas below the scar. Mean monofilament values were calculated for the total donor site and compared between groups.	Through study completion up to 36 months postoperatively

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: DIEP flap; Breast reconstruction; Sensory recovery; Nerve coaptation; Breast sensation
• Other Study ID Numbers: METC 16 - 4 - 147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No