Clinical trial NCT05484934: Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Mastectomy Breast Deformity (Disorder)
Lead sponsor: BioAesthetics
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Time to complete healing (graft >99% re-epithelialized)
timeFrame: 3 months
measure: Healing of the nipple (VAS=Visual Analog Scale) epithelialization
timeFrame: 3 months
measure: Healing of the nipple (VAS=Visual Analog Scale) granulation
timeFrame: 3 months
measure: Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis
timeFrame: 3 months
measure: Healing of the nipple (VAS=Visual Analog Scale) dehiscence
timeFrame: 3 months
measure: Healing of the nipple (VAS=Visual Analog Scale) overall healing
timeFrame: 3 months
measure: Healing of the nipple (infection) A. no infection B. hyperemia (no infection) C. cellulitis (superficial infection D. abscess or purulent infection
timeFrame: 3 months
Secondary outcomes:
measure: Nipple projection
timeFrame: 12 months
measure: Vascularization by presence of bleeding
timeFrame: 12 months
measure: Evaluate patient satisfaction and well-being preoperatively and serially
timeFrame: 12 months
Other outcomes:
measure: Operative time in minutes
timeFrame: 12 months
measure: Physician Preference and Impressions
timeFrame: 12 months
measure: Nipple sensitivity up to 12 months
timeFrame: 12 months
Locations:
city: New Orleans
country: United States
facility: St. Charles Surgical Hospital
state: Louisiana
Study officials:
affiliation: MedSurgPI, LLC
name: Roger Morgan, MD
role: STUDY_CHAIR
References: