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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Post-Mastectomy Breast Deformity (Disorder)
• Intervention / Treatment: Procedure: Regenerative post mastectomy surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Van Vactor; Phone Number: 9196049708; Email: svanvactor@medsurgpi.com
• Study Contact Backup: Name: Gerald L. Klein, MD; Phone Number: 919-930-9180; Email: gklein@medsurgpi.com

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70130
      • Recruiting
      • St. Charles Surgical Hospital
      • Contact: Scott Sullivan, MD; Phone Number: 504-899-2800; Email: scottsullivanmd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Implant of acellular NAC graft; The implantation of the NAC acellular graft for regenerative nipple areolar complex	Procedure: Regenerative post mastectomy surgery; Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC); Other Names: Implantation of the NAC graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete healing (graft >99% re-epithelialized)	To evaluate the time to complete healing following NAC reconstruction with DCLNAC.	3 months
Healing of the nipple (VAS=Visual Analog Scale) epithelialization	epithelialization (0-100% VAS)	3 months
Healing of the nipple (VAS=Visual Analog Scale) granulation	granulation (0-100% VAS)	3 months
Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis	ischemia/necrosis (0-100% VAS)	3 months
Healing of the nipple (VAS=Visual Analog Scale) dehiscence	dehiscence (0-100% VAS)	3 months
Healing of the nipple (VAS=Visual Analog Scale) overall healing	overall healing (0-100% VAS)	3 months
Healing of the nipple (infection) A. no infection B. hyperemia (no infection) C. cellulitis (superficial infection D. abscess or purulent infection	As above	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nipple projection	Distance from breast mound to tip in millimeters using depth gauge.	12 months
Vascularization by presence of bleeding	vascularization by presence of bleeding using a lancet device	12 months
Evaluate patient satisfaction and well-being preoperatively and serially	Use of a standardized postoperative survey with a LIKERT (numerical) scale up to 12 months following reconstruction.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time in minutes	One hour	12 months
Physician Preference and Impressions	Using a standardized survey (0-10 VAS Scale)	12 months
Nipple sensitivity up to 12 months	Using Semmes Weinstein Monofilament	12 months

Collaborators and Investigators

• Sponsor: BioAesthetics
• Investigators: Study Chair: Roger Morgan, MD, MedSurgPI, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 21, 2022
• Primary Completion (ANTICIPATED): August 7, 2024
• Study Completion (ANTICIPATED): October 7, 2024

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (ACTUAL): August 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: BA002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No