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Nipple-Areola Complex Grafts for Breast Reconstruction After Cancer
Study Summary
This trial will study the safety and healing of nipple-areola complex reconstruction using BioAesthetics' decellularized human nipple-areolar complex graft.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have another medical condition that is not being well-managed.My BMI is either below 18.5 or above 40.I agree to avoid aspirin, alcohol, and too much caffeine for 6 weeks.You have had an allergic reaction to any product made from a decellularized biologic matrix.I have had nipple-areola complex tattooing.I want nipple-areola complex grafting 3 months after my breast reconstruction.I agree not to get NAC tattooing until after 12 months.You are currently smoking or using tobacco or nicotine products, or have used them in the last 12 months.I am between 18 and 65 years old.I understand the study and agree to participate.I am currently undergoing or have had radiation therapy to the breast area.I have diabetes (Type I or Type II).My wounds take longer to heal than usual.I have had nose surgery before.
- Group 1: NACgraft patients
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
For whom is this medical experiment available?
"This clinical trial is enrolling 15 individuals with breast cancer, aged between 18 and 65. The following additional criteria must be met in order to participate: abstaining from aspirin, alcohol or excessive caffeine for 6 weeks; not undergoing NAC tattooing for 12 months; sleeping on back until grafts healed (6 weeks)."
What is the current capacity for enrolment in this clinical trial?
"Affirmative. According to data provided by clinicaltrials.gov, this medical trial was initiated on April 28th 2021 and is currently recruiting participants for its study. At the moment, 15 patients are needed from 1 site."
Is there capacity for additional participants in this trial?
"Indeed, the information posted on clinicaltrials.gov substantiates that this scientific research is currently in search of participants. Originally published on April 28th 2021, it was recently amended on May 3rd 2022 and requires 15 individuals to be recruited from a single location."
Is eligibility for this study restricted to individuals under the age of sixty?
"According to the prerequisites for enrolment, only individuals between 18 and 65 years old are eligible. Those looking for studies related to younger people have 52 options while those seeking trials involving senior patients can pick from 1335 different ones."
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