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Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04093999
Enrollment
126
Registered
2019-09-18
Start date
2016-08-01
Completion date
2019-09-01
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast reconstruction, DIEP flap, Sensory recovery, Breast sensation, Nerve coaptation

Brief summary

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.

Interventions

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.

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean monofilament value as a measure for the sensory recovery of the reconstructed breastThrough study completion up to 36 months postoperativelyThe 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.

Secondary

MeasureTime frameDescription
Mean monofilament value as a measure for the sensory recovery of the reconstructed breastThrough study completion up to 36 months postoperativelyThe 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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026