Open Label Case Reports Investigating Wound Healing, Aesthetic Outcomes, and Patient Satisfaction Following Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)

  • STATUS
    Recruiting
  • End date
    Oct 7, 2024
  • participants needed
    36
  • sponsor
    BioAesthetics
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Updated on 25 October 2022
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Summary

To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)

Description

Primary Objective

• To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC).

Secondary Objectives

  • To evaluate nipple dimensions and vascularization up to 12 months following nipple reconstruction using DCLNAC.
  • To evaluate patient satisfaction and well-being up to 12 months following nipple reconstruction using DCLNAC.

Exploratory Objectives

  • To assess operative time and physician preference for either the DCLNAC or the standard of care (SOC) surgical NAC reconstruction procedures.
  • To evaluate nipple sensitivity.

Details
Condition Post-Mastectomy Breast Deformity (Disorder)
Treatment Regenerative post mastectomy surgery
Clinical Study IdentifierNCT05484934
SponsorBioAesthetics
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

General Criteria
Females age >18 and <65 years old. Women of childbearing potential must agree to use an acceptable method of contraception for one month prior to DCLNAC implantation, and until the graft is 100% healed. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap. Nonchildbearing potential for women is defined as postmenopausal (last natural menses greater than 12 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 12 months, a serum FSH value confirming post-menopausal status can be employed
Patient agrees to sleep on back until study tissue products are healed
Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until study tissue products are healed
Patient agrees to not undergo NAC tattooing until completing study
Patient can understand and willing to sign informed consent
Patient desires bilateral nipple reconstruction with DCLNAC
Subjects must be capable of providing written informed consent to the study procedures and for use of protected health information [Health Insurance Portability and Accountability Act (HIPAA), if applicable]
Specific Criteria
Group A
Patient had a bilateral mastectomy with no radiation therapy
Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Group B
Patient had a unilateral mastectomy with no radiation therapy
Patient has undergone a unilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Group C
Patient had a bilateral mastectomy and received radiation unilaterally
Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Group D
Patient had unilateral or bilateral mastopexy (with or without augmentation) or reduction mammaplasty and suffered nipple complications (i.e., necrosis, projection loss)
Group E
Patient had unilateral or bilateral mastectomy
Patient had unilateral or bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study
Patient did not receive radiation to the autologously reconstructed breast
Patient had unilateral or bilateral nipple reconstruction that failed (i.e., necrosis, projection loss)
Group F
Implant based reconstruction

Exclusion Criteria

Patient has a history of delayed wound healing
Patient has a history of Vitamin C deficiency
BMI<18.5 or >40 kg/m2
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, vaping or nasal spray) or has used such products in the past 6 months
Patient is currently receiving bilateral breast radiation or completed less than 3 months prior to screening
Patient has any systemic disease that would impede wound healing, such as diabetes or connective tissue disorders
Patient is pregnant, breastfeeding or planning to become pregnant during the study period
Patient has any type of disease or disorder that in the investigator's opinion would make the patient unfit for the study, including active infection anywhere in the body
Acute mastitis in either breast
History of an autoimmune disorder
Use of any medications currently or in the past 3 months that would impair wound healing, such as long-term use of systemic steroids (inhaled, limited topical, short-term oral use and intra-articular steroids are acceptable)
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