Sensory Nerve Coaptation 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensory Nerve Coaptation

Procedure

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, Reinnervation, Neurorrhaphy

Primary outcomes

Mean monofilament value as a measure for the sensory recovery of the reconstructed breast

Time frame: Through study completion up to 36 months postoperatively

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.

Secondary outcomes

Mean monofilament value as a measure for the sensory recovery of the reconstructed breast

Time frame: Through study completion up to 36 months postoperatively

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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Sep 18, 2019
Registry last updated: Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed