Status:
RECRUITING
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
Lead Sponsor:
Patricia Esther Engels
Conditions:
Breast Cancer Surgery
Reconstruction Breast Surgery
Eligibility:
FEMALE
18-80 years
Phase:
NA
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 reconstruct...
Detailed Description
Breast reconstruction with autologous tissue is one of the most important methods: The DIEP (deep inferior epigastric artery perforator) flap is today's workhorse in autologous reconstruction. Routine...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06930378
Start Date
April 1 2025
End Date
February 1 2029
Last Update
April 16 2025
Active Locations (1)
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1
Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland, 1205