NCT06930378 Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
| NCT ID | NCT06930378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Patricia Esther Engels |
| Condition | Breast Cancer Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2025-04 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 63 participants in total. It began in 2025-04 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Patricia E Engels, MD
PRINCIPAL INVESTIGATOR
University Hospital, Geneva
Frequently Asked Questions
Who can join the NCT06930378 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Breast Cancer Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06930378 currently recruiting?
Yes, NCT06930378 is actively recruiting participants. Contact the research team at patricia.engels@hug.ch for enrollment information.
Where is the NCT06930378 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT06930378 clinical trial?
NCT06930378 is sponsored by Patricia Esther Engels. The principal investigator is Patricia E Engels, MD at University Hospital, Geneva. The trial plans to enroll 63 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.