Sensory Restoration in DIEP Free Flaps for Post-Mastectomy Breast Reconstruction After Breast Cancer: Comparing Non-sensitized Standard Technique to Direct Nerve Suture and to Autograft: A Three-arm, Randomized, Double-blinded Superiority Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
Switzerland
Geneva University Hospitals
RECRUITING
Geneva
Contact Information
Primary
Patricia E Engels, MD
patricia.engels@hug.ch
+41795537557
Backup
Axelle Serre, MD
axelle.serre@usb.ch
+41795538642
Time Frame
Start Date: 2025-04
Estimated Completion Date: 2029-02
Participants
Target number of participants: 63
Treatments
No_intervention: no nerve suture
No nerve suture will be carried out.
Experimental: direct nerve suture
Epineural coaptation of one nerve of the flap to one nerve of the breast region
Experimental: interposition of an autograft
Epineural coaptation intercostal nerve flap to autograft (from another intercostal nerve of the flap) to intercostal nerve of the breast = interposition of an autograft
Related Therapeutic Areas
Sponsors
Leads: Patricia Esther Engels

This content was sourced from clinicaltrials.gov