Comparing surgical techniques for improving breast skin sensitivity after reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of nerve sutures in enhancing skin sensitivity in patients undergoing DIEP flap breast reconstruction due to breast cancer or genetic conditions. Participants aged 18 to 80 will be randomized into three groups: one receiving direct nerve sutures, another receiving an autograft, and a control group with no nerve sutures. The primary outcome will be assessed through sensory testing at 12 months post-surgery, alongside quality of life questionnaires and skin biopsies for proteomic analysis. The goal is to establish a standard method for sensitized flap-based breast reconstruction.

Why it matters

Who can join: the full rules

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

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Geneva University Hospitals
  Geneva, Canton of Geneva, Switzerland Recruiting

Study contacts

• Principal investigator: Patricia E Engels, MD — University Hospital, Geneva
• Study coordinator: Patricia E Engels, MD
• Email: patricia.engels@hug.ch
• Phone: +41795537557

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.