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

Launched by PATRICIA ESTHER ENGELS · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how different surgical techniques can improve the feeling in the skin of the breast after reconstruction surgery for women who have had a mastectomy due to breast cancer or genetic conditions. Specifically, the study is examining whether using nerve sutures during a type of surgery called DIEP flap breast reconstruction can help patients feel pressure better in the reconstructed breast after one year. The researchers want to find out if these nerve sutures can also improve overall quality of life, which they will measure through questionnaires completed by participants at 12 and 24 months after surgery.

To participate in this study, women aged 18 to 80 who are having DIEP flap breast reconstruction may be eligible. However, certain factors might exclude someone from joining, like having specific neurological conditions, receiving certain treatments like radiation therapy, or being pregnant or breastfeeding. Participants will attend regular check-ups where their breast sensitivity will be tested, they will fill out questionnaires, and small skin samples will be taken for further analysis. This trial aims to provide valuable insights into how to enhance recovery and comfort for women undergoing breast reconstruction.

Gender

FEMALE

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