Clinical Trial

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

Study acronym: S-DIEP
Recruiting
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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.
Trial Details
NCT Number NCT06930378
Lead Sponsor Patricia Esther Engels
Conditions Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization, DIEP Flap Breast Reconstruction
Enrollment 63 participants
Start Date 2025-04
Primary Completion 2028-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2025-04-16