Comparing surgical techniques for improving breast skin sensitivity after reconstruction

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

This study is testing if using special nerve stitches during breast reconstruction can help improve skin sensitivity for women who have had surgery for breast cancer or genetic conditions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: University Hospital, Geneva (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Geneva, Canton of Geneva)
• Trial ID: NCT06930378 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 80 who are undergoing unilateral DIEP flap breast reconstruction.

Not a fit: Patients who have undergone postoperative radiotherapy on the flap or have severe neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve sensory recovery and quality of life for patients undergoing breast reconstruction.

How similar studies have performed: While the approach of nerve sutures in breast reconstruction is innovative, no previous studies have specifically analyzed the sensory recovery in this context, making this a novel investigation.

Eligibility criteria

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 this trial is running

Geneva, Canton of Geneva

• 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

Conditions: Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization, DIEP Flap Breast Reconstruction, free flap, breast reconstruction, autologous-based reconstruction, neurotization