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
Sponsors and collaborators
Patricia Esther Engels
Lead sponsor
University Hospital, Geneva
Sponsor institution