RecruitingNot ApplicableNCT06930378

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

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

Sponsor

Patricia Esther Engels

Enrollment

63 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Surgery Reconstruction Breast Surgery Sensitization DIEP Flap Breast Reconstruction

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

A) Pilot study
years old
having received DIEP flap breast reconstruction with a flap not completely buried
having given written informed consent for participating in the study
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 Criteria13

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
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

Interventions

PROCEDURENerve Suture

Sensory nerve coaptations will be performed 1. either by suturing the donor to the recipient nerve immediately (1 coaptation) 2. or by interposing an autograft originating from the zone of the flap to be discarded (2 coaptations). The anterior cutaneous branch (ACB) of the 3rd or 4th intercostal nerve (ICN) will be connected to the sensory branch of the 10th, 11th or 12th ICN of the flap.