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

NCT ID: NCT05484934

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2024-10-07

Brief Summary

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

Detailed 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.

Conditions

Post-Mastectomy Breast Deformity (Disorder)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implant of acellular NAC graft

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

Group Type: EXPERIMENTAL

Regenerative post mastectomy surgery

Intervention Type: PROCEDURE

Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)

Interventions

Regenerative post mastectomy surgery

Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)

Intervention Type: PROCEDURE

Other Intervention Names

Implantation of the NAC graft

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

BioAesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Morgan, MD

Role: STUDY_CHAIR

MedSurgPI, LLC

Locations

St. Charles Surgical Hospital

New Orleans, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Susan Van Vactor

Role: CONTACT

svanvactor@medsurgpi.com

9196049708

Gerald L. Klein, MD

Role: CONTACT

gklein@medsurgpi.com

919-930-9180

Facility Contacts

Scott Sullivan, MD

Role: primary

scottsullivanmd@gmail.com

504-899-2800

Other Identifiers

BA002

Identifier Type: -

Identifier Source: org_study_id