Breast Implant; Complications, Infection or InflammationNCT05744414
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
An observational study of Breast Implant; Complications, Infection or Inflammation, run by AlloSource at 1 site in United States.
Trial summary
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Implant; Complications, Infection or Inflammation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2023to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults 18 years of age or greater who have undergone a pre-pectoral placement of tissue expanders for breast reconstruction and will have a histological evaluation of the AlloMend® Acellular Dermal Matrix and native tissue at time of permanent breast implantation
Who may be able to join
- ≥18 years of age;
- AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction;
- Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant;
- Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol.
Who cannot join
- Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study;
- Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Janiga MDs Plastic Surgery and Cosmetic Center
Reno, Nevada, 89521
About this study
Official title: Histological Analysis of AlloMend® Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix.
AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.
Read the detailed description
The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis.
This study will be performed at one (1) clinical center in the United States.
- Medical subject headings
- Infections, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application
The primary endpoint being evaluated in this study is AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application. The endpoint will be analyzed from biopsied tissue samples taken during the exchange of expander to permanent breast implant using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen.
Measured: At expander/implant exchange surgery; typically 1-3 months post expander placement
Secondary outcomes (5)
Infection rates
Information collected through clinical standard of care
Measured: Up to 6 months post expander/implant exchange
Seroma rates
Information collected through clinical standard of care
Measured: Up to 6 months post expander/implant exchange
Hematoma rates
Information collected through clinical standard of care
Measured: Up to 6 months post expander/implant exchange
Drain outputs and timing of drain removal
Information collected through clinical standard of care
Measured: Up to 6 months post expander/implant exchange
Revision surgeries
Information collected through clinical standard of care
Measured: Up to 6 months post expander/implant exchange
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start17 May 2023
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant; Complications, Infection or InflammationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlloSource
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744414
- Sponsor's protocol ID
- ADM-002
- Status last verified
- Nov 2025
- First submitted
- 9 Feb 2023
- Last updated
- 21 Nov 2025
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Analysis of AlloMend® Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation
- ClinicalTrials.gov ID
- NCT05744414
- Acronym / sponsor ID
- ADM-002
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AlloSourceIndustry (pharma, biotech, devices)
- Study start
- 17 May 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 27 Feb 2023 (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.
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix.
AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.
Detailed description
The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis.
This study will be performed at one (1) clinical center in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 years of age or greater who have undergone a pre-pectoral placement of tissue expanders for breast reconstruction and will have a histological evaluation of the AlloMend® Acellular Dermal Matrix and native tissue at time of permanent breast implantation
Key inclusion criteria (4 listed)
- ≥18 years of age;
- AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction;
- Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant;
- Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol.
Key exclusion criteria (2 listed)
- Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study;
- Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application
Time frame: At expander/implant exchange surgery; typically 1-3 months post expander placement
The primary endpoint being evaluated in this study is AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application. The endpoint will be analyzed from biopsied tissue samples taken during the exchange of expander to permanent breast implant using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen.
5 secondary outcomes
Infection rates
Time frame: Up to 6 months post expander/implant exchange
Seroma rates
Time frame: Up to 6 months post expander/implant exchange
Hematoma rates
Time frame: Up to 6 months post expander/implant exchange
Drain outputs and timing of drain removal
Time frame: Up to 6 months post expander/implant exchange
Revision surgeries
Time frame: Up to 6 months post expander/implant exchange
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant; Complications, Infection or Inflammation, run by AlloSource 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application (time frame: At expander/implant exchange surgery; typically 1-3 months post expander placement). 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 21 Nov 2025.