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

Not Applicable

Recruiting

• Conditions: Post-Mastectomy Breast Deformity (Disorder)

• Registration Number: NCT05484934
• Lead Sponsor: BioAesthetics

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.

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-02
• Study Start: 2022-09-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2024-08-07
• Study Completion: 2024-10-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Charles Surgical Hospital; 🇺🇸 New Orleans, Louisiana, United States