Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Te… (NCT06930378) | Clinical Trial Compass
RecruitingNot Applicable
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
Switzerland63 participantsStarted 2025-04
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
A) Pilot study
Inclusion criteria:
* 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
Exclusion criteria:
* 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
* pregnancy or lactating women
B) Main study
Inclusion Criteria:
* 18 to 80 years old
* having given written informed consent for participating in the study
* receiving immediate or delayed unilateral DIEP breast reconstruction with a DIEP flap which will not be completely buried
Exclusion Criteria:
* autologous reconstruction where the flap is completely buried
* patients in need of both-sided reconstruction (double DIEP)
* 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
* pregnancy at time of planned DIEP flap surgery and lactation