Post-Mastectomy Breast Deformity (Disorder)NCT05484934
Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
A study testing Regenerative post mastectomy surgery in people with Post-Mastectomy Breast Deformity (Disorder), run by BioAesthetics at 1 site in United States.
Trial summary
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC) Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-Mastectomy Breast Deformity (Disorder)
- What is being tested?
- Regenerative post mastectomy surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Charles Surgical Hospital
New Orleans, Louisiana, 70130
Scott Sullivan, MD, 504-899-2800, scottsullivanmd@gmail.com
About this study
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)
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
Read the 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.
- Being tested
- Regenerative post mastectomy surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative post mastectomy surgeryProcedure or surgery
Also called Implantation of the NAC graft
Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)
| Study group | Role | What they receive |
|---|---|---|
| Implant of acellular NAC graft | Experimental | The implantation of the NAC acellular graft for regenerative nipple areolar complex Receives: Procedure: Regenerative post mastectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing (graft >99% re-epithelialized)
To evaluate the time to complete healing following NAC reconstruction with DCLNAC.
Measured: 3 months
Healing of the nipple (VAS=Visual Analog Scale) epithelialization
epithelialization (0-100% VAS)
Measured: 3 months
Healing of the nipple (VAS=Visual Analog Scale) granulation
granulation (0-100% VAS)
Measured: 3 months
Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis
ischemia/necrosis (0-100% VAS)
Measured: 3 months
Healing of the nipple (VAS=Visual Analog Scale) dehiscence
dehiscence (0-100% VAS)
Measured: 3 months
Healing of the nipple (VAS=Visual Analog Scale) overall healing
overall healing (0-100% VAS)
Measured: 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
Measured: 3 months
Secondary outcomes (3)
Nipple projection
Distance from breast mound to tip in millimeters using depth gauge.
Measured: 12 months
Vascularization by presence of bleeding
vascularization by presence of bleeding using a lancet device
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start21 Sep 2022
- Primary completion7 Aug 2024 (estimated)
- Study completion7 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Mastectomy Breast Deformity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioAesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Morgan, MD, Study chair, MedSurgPI, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484934
- Sponsor's protocol ID
- BA002
- Status last verified
- Oct 2022
- First submitted
- 13 Jul 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05484934
- Acronym / sponsor ID
- BA002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- BioAestheticsIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 7 Aug 2024 (estimated)
- Study completion
- 7 Oct 2024 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant of acellular NAC graft | Experimental | Procedure: Regenerative post mastectomy surgeryThe implantation of the NAC acellular graft for regenerative nipple areolar complex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- General Criteria:
- 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
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenerative post mastectomy surgeryAlso: Implantation of the NAC graftImplantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC) | Procedure or surgery | Implant of acellular NAC graft |
Primary outcome
Time to complete healing (graft >99% re-epithelialized)
Time frame: 3 months
To evaluate the time to complete healing following NAC reconstruction with DCLNAC.
Healing of the nipple (VAS=Visual Analog Scale) epithelialization
Time frame: 3 months
epithelialization (0-100% VAS)
Healing of the nipple (VAS=Visual Analog Scale) granulation
Time frame: 3 months
granulation (0-100% VAS)
Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis
Time frame: 3 months
ischemia/necrosis (0-100% VAS)
Healing of the nipple (VAS=Visual Analog Scale) dehiscence
Time frame: 3 months
dehiscence (0-100% VAS)
Healing of the nipple (VAS=Visual Analog Scale) overall healing
Time frame: 3 months
overall healing (0-100% VAS)
Healing of the nipple (infection) A. no infection B. hyperemia (no infection) C. cellulitis (superficial infection D. abscess or purulent infection
Time frame: 3 months
As above
3 secondary outcomes
Nipple projection
Time frame: 12 months
Vascularization by presence of bleeding
Time frame: 12 months
Evaluate patient satisfaction and well-being preoperatively and serially
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Morgan, MD study chair
MedSurgPI, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative post mastectomy surgery in people with Post-Mastectomy Breast Deformity (Disorder), run by BioAesthetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Van Vactor (9196049708, svanvactor@medsurgpi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete healing (graft >99% re-epithelialized) (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.