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Completed

NCT Number: NCT03428789

Nerve Coaptation in DIEP Flap Breast Reconstruction

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated DIEP flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between September 2015 and July 2017. Semmes-Weinstein monofilaments were used for sensory testing of the breast. This study showed that nerve coaptation in DIEP flap breast reconstruction resulted in a significantly improved sensation of the reconstructed breast compared to non-innervated flaps.

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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 September 2015 and July 2017
  • Informed consent

Exclusion criteria

  • Bilateral breast reconstruction with a unilateral innervated DIEP flap and a contralateral non-innervated flap
  • Flaps that required a take-back

Treatment and study plan

Sensory Nerve Coaptation

Procedure

A recipient sensory nerve of the abdomen was reattached to a donor nerve in the chest area. The sensory branch of usually the 11th intercostal nerve was used as recipient nerve for nerve coaptation and the anterior cutaneous branch of the third intercostal nerve was used as donor nerve. Direct, end-to-end nerve coaptation was performed with two stitches.

Other names: Neurotization, Neurorrhaphy, Reinnervation

Primary outcomes

  1. The extent of sensory recovery of the reconstructed breast to touch

    Time frame: Through study completion up to 24 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Sensory Recovery of the Breast Following Innervated and Non-innervated DIEP Flap Breast Reconstructions

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2018
Registry last updated
Feb 19, 2018

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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