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

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

Plain Language Summary

Simplified for easier understanding

This study compares three surgical techniques for breast reconstruction to see which one best preserves or restores feeling (sensation) in the breast skin after a DIEP flap reconstruction — a procedure that uses tissue from the abdomen to rebuild the breast. **You may be eligible if...** - You are between 18 and 80 years old - You are receiving or have received a DIEP flap breast reconstruction - You agree to participate in study procedures including photographs **You may NOT be eligible if...** - You will receive or received radiation therapy on the reconstructed breast - You have nerve damage conditions such as diabetic neuropathy, alcohol-related nerve damage, or chemotherapy-induced neuropathy - You are currently an active smoker - You are pregnant or breastfeeding - You need reconstruction on both breasts (double DIEP) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland

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NCT06930378


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