OPEN Research Support
head

Professor, consultant plastic surgeon
Tine Engberg Damsgaard MD, PhD, MRBS
Department of Surgery and Plastic Surgery, University Hospital of Southern Denmark, SLB-Vejle


Project management
Project status    Open
 
Data collection dates
Start 01.01.2026  
End 31.12.2026  
 



SENSI-Breast (pilot) Nerve Preservation in Immediate Breast Reconstruction. A pilot study on sensibility-preserving mastectomy and breast reconstruction.

Short summary

This pilot study will investigate the feasibility and the outcome of neurotization of the nipple-areola complex in immediate breast reconstruction. The study will encompass 6 patients undergoing nipple-sparing mastectomi with reconstruction, investigating the sensory recovery after surgery, and as well evaluate the patient reported QoL, postoperative complications and the aesthetic outcome.


Rationale

As of today, the standard approach in immediate breast reconstruction leaves the patient with a breast with significantly diminished sensation and in the case of nipple-sparing mastectomy a nipple/areola complex with no sensation at all. Recently American colleagues developed a novel concept and procedure combining breast reconstruction with peripheral nerve surgery With the aim of investigating this concept and thus adressing an umeet need, the present study is designed


Description of the cohort

The study is carried out as an observational clinical, feasibility study.. The pilot study will encompass a 6 patients at the University Hospital of Southern Denmark, Department of Surgery and Plastic Surgery, SLB-Vejle. It will serve as a feasibility study. The patients will undergo nipple-sparing mastectomy with immediate breast reconstruction and nerve preservation - the indication being prophylactic or therapeutic. In patients with a subcutaneous course of the relevant intercostal nerve, nerve-coaptation will be performed using the nerve-connector (Axoguard nerve connector, https://www.axogeninc.com/products/axoguard-nerve-connector). Patients with an intraparenchymal, but insufficiently short course of the relevant intercostal nerve will not undergo neurotization. Planned number of patients =6.


Data and biological material

None


Collaborating researchers and departments

Department of Surgery and Plastic Surgery, University Hospital of Southern Denmark, SLB-Vejle

  • Consultant plastic surgeon, post doc Bekka Christensen, MD, PhD

Sutter Health California Pacific Medical Center, San Francisco, California, USA (

  • Anne Peled, MD
  • Ziv Peled MD PhD