Actively Recruiting
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
Led by Patricia Esther Engels · Updated on 2025-04-16
63
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years
- Planning or having received unilateral DIEP flap breast reconstruction with a flap not completely buried
- Provided written informed consent to participate in the study
You will not qualify if you...
- Postoperative radiotherapy on the flap
- Neurological conditions such as diabetic neuropathy, alcoholism, chemotherapy-induced neuropathy, or other severe peripheral neuropathies
- Active smoking
- Language barrier
- Pregnancy or lactating at the time of planned DIEP flap surgery
- Autologous reconstruction with flap completely buried
- Patients requiring bilateral (both-sided) DIEP breast reconstruction
AI-Screening
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Trial Site Locations
Total: 1 location
1
Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland, 1205
Actively Recruiting
Research Team
P
Patricia E Engels, MD
CONTACT
A
Axelle Serre, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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