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

NCT06930378 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-04-16

No results posted yet for this study

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.

Conditions

  • Breast Cancer Surgery
  • Reconstruction Breast Surgery
  • Sensitization
  • DIEP Flap Breast Reconstruction

Interventions

PROCEDURE

Nerve 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.

Sponsors & Collaborators

  • Patricia Esther Engels

    lead OTHER

Principal Investigators

  • Patricia E Engels, MD · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2028-02-29
Completion
2029-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930378 on ClinicalTrials.gov