Trial results for a study evaluating decellularized human nipple-areolar complex (dcl-hNAC) grafts in Breast Cancer patients were posted on ClinicalTrials.gov on 2025-12-17, reporting 8 grafts with complete healing.
Background
Breast cancer treatment often involves mastectomy, which can significantly impact a patient's body image and psychological well-being. Nipple-areola complex (NAC) reconstruction is a crucial step in the reconstructive process, aiming to restore a more natural appearance after breast removal. The study aimed to assess the safety and healing time of the BioAesthetics' dcl-hNAC graft for NAC reconstruction in patients who had undergone autologous breast reconstruction for breast cancer. Secondary objectives included evaluating patient satisfaction, well-being, self-esteem, body image, psychological well-being, nipple dimensions, and sensitivity following the reconstruction surgery.
Trial design
This study, designated as Phase NA, was terminated and enrolled 6 participants with Breast Cancer. The trial investigated the use of decellularized, whole donor nipple-areola complex reconstruction grafts (dcl-hNAC grafts) for nipple-areolar complex reconstruction. The primary objectives, as stated, were to evaluate the safety and healing time of the dcl-hNAC graft. No specific primary outcome measures were reported in the provided data.
Key results
The trial reported on the number of grafts that achieved complete healing:
- Among patients receiving the NACgraft, the number of grafts with complete healing was 8 grafts.
The study's overall status was TERMINATED.
What this means
The reported finding of 8 grafts achieving complete healing with the dcl-hNAC graft provides specific data on a key aspect of nipple-areola complex reconstruction in breast cancer patients. While the trial was terminated and involved a small number of participants, this result offers preliminary insight into the healing potential of this reconstructive approach. Further research would be needed to fully understand the long-term safety, efficacy, and patient-reported outcomes, especially given the termination of this study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04534010, titled "Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts", were posted on 2025-12-17 on clinicaltrials.gov.