Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorPatricia Esther Engels

About this trial

The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or genetic conditions. Affected women 18 to 80 years old can be included. The main question is:

If a nerve suture was carried out, can pressure be felt better on the reconstructed breast after 12 months? If a nerve suture was carried out, will better sensibility and quality of life be felt and perceived (questionnaire) at 12 and 24 months after the initial operation ? Researchers will compare two different nerve suture techniques and no nerve suture to one another to see if and which nerve suture optimizes sensibility.

Participants will have regular visits and follow-up controls, during which

* their sensibility will be tested multimodally, * they will fill out questionnaires * skin biopsies will be taken.

Eligibility criteria

Qualifiers

18-80 years old

having received DIEP flap breast reconstruction with a flap not completely buried

having given written informed consent for participating in the study

Disqualifiers

postoperative radiotherapy on the flap

neurological conditions as diabetic neuropathy, alcoholism or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications

active smoking

language barrier

Trial design

Treatments tested in this trial

  • Nerve Suture

Treatment groups

63 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Patricia Esther Engels

Lead sponsor

University Hospital, Geneva

Sponsor institution