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Regenerative Surgery for Post-Mastectomy Breast Deformity
Study Summary
This trial tested the effectiveness of a donor graft to help heal wounds from nipple-areolar complex reconstruction surgery.
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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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- I am planning to have breast reconstruction using implants.I had breast lift or reduction surgery and experienced nipple complications.I agree not to get NAC tattooing until the study is over.I do not have any health conditions that would make me unfit for the study.I am currently undergoing or recently finished breast radiation.I have an infection in one or both of my breasts.I want both nipples reconstructed using DCLNAC.I am a woman aged between 18 and 65.I do not have conditions like diabetes that could affect wound healing.I am a woman who cannot become pregnant because I am postmenopausal, have had my tubes tied, or have had a hysterectomy.I agree to avoid aspirin, alcohol, and too much caffeine until my study-related procedures are healed.I had both breasts removed, no radiation, and my own tissue used for reconstruction over 3 months ago.I haven't taken any medication in the past 3 months that could affect wound healing.I had breast reconstruction without radiation and my nipple reconstruction failed.I had a mastectomy on one breast without radiation and got a reconstruction using my own tissue over 3 months ago.I had both breasts removed, radiation on one side, and tissue-based reconstruction over 3 months ago.
- 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.
- Group 1: Implant of acellular NAC graft
Frequently Asked Questions
Is there currently an open enrollment period for this clinical trial?
"Affirmative. According to the records on clinicaltrials.gov, this examination is still open for enrollments with a post date of September 21st 2022 and an update on October 13th 2022. The study aims to recruit 36 participants at 1 location."
Is the research initiative accepting volunteers over two decades old?
"For adults aged 18 to 65, this clinical trial serves as an opportunity for medical research. In contrast, there are 49 studies specifically targeting minors and 77 trials tailored toward seniors over the age of 65."
To what extent is this clinical trial open to participants?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial has been actively seeking participants since its posting date on September 21st 2022, with the last edit occuring October 13th 2022. 36 prospective patients are being recruited from a single medical centre for this study."
Are there particular cohorts that are more ideal for enrollment in this clinical investigation?
"This clinical trial seeks 36 participants aged 18 to 65 that have undergone a bilateral mastectomy and autologous breast reconstruction at least 3 months prior. Furthermore, female patients must take measures to avoid pregnancy for one month before the grafting procedure as well as during recovery. These could include abstinence or any double combination of: intrauterine device (IUD), male/female condom, diaphragm, sponge, and cervical cap etc. Additionally all subjects must be able to comprehend the study procedures thoroughly in order to provide informed consent according their HIPAA rights if applicable."
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