Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft

BioAesthetics

Status: Enrolling

Conditions: Post-Mastectomy Breast Deformity (Disorder)

Treatments: Procedure: Regenerative post mastectomy surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT05484934

BA002

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Implant of acellular NAC graft

Experimental group

Description:

The implantation of the NAC acellular graft for regenerative nipple areolar complex

Treatment:

Procedure: Regenerative post mastectomy surgery