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

B

BioAesthetics

Status

Enrolling

Conditions

Post-Mastectomy Breast Deformity (Disorder)

Treatments

Procedure: Regenerative post mastectomy surgery

Study type

Interventional

Funder types

Industry

Identifiers

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)

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

Trial contacts and locations

1

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Central trial contact

Susan Van Vactor; Gerald L. Klein, MD

Data sourced from clinicaltrials.gov

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