Clinical trial · Interventional
Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision due to low accrual
Summary
Brief summary (as posted)
The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NACgraft | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NACgraft patients
- description
- uni- or bilateral engraftment surgery will be performed
- interventionNames
- Device: NACgraft
Primary outcomes (1)
- measure
- Number of Grafts With Complete Healing
- timeFrame
- 3, 6 and 12 months
- description
- Complete is defined as when the graft is \>99% epithelialized. Degree of healing will be based on visual assessment by the surgeon and central reviewer with the following metrics on a visual analog scale (VAS): epithelialization (0-100%); granulation (0-100%); overall healing (0-100%). Photographs will be taken using a standardized 3d imaging device, stored and transmitted securely to a central reviewer for independent review.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age 18-65 * Patient desires NAC grafting ≥3 months after autologous breast reconstruction * Patient agrees to sleep on back until grafts healed (6 weeks) * Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks) * Patient agrees to not undergo NAC tattooing until completing study (12 months) * Patient is able to understand and willing to sign informed consent. Exclusion Criteria: * History of delayed wound healing * history of Vitamin C deficiency * history of diabetes (Type I or Type II) * current BMI\<18.5 or \>40 kg/m, * patient has any other uncontrolled comorbidity. * Patient has a history of allergic reaction to any decellularized biologic matrix product. * Patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months. * Patient is currently receiving radiation or chemotherapy or received radiation to the breast wall. * Patient has a history of prior NAC reconstruction * Patient has had NAC tattooing. * Patient is pregnant, breastfeeding or planning to become pregnant during the study period.
References
Publications (0)
Data not yet available