Pre-Pectoral Breast Reconstruction Following MastectomyNCT06853964
Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction
An observational study of Pre-Pectoral Breast Reconstruction Following Mastectomy, run by AlloSource at 1 site in United States.
Trial summary
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Pectoral Breast Reconstruction Following Mastectomy
- What is being tested?
- AlloMend® Acellular Dermal Matrix allograft
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2025to 31 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients who require a single or double mastectomy and have undergone Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.
Who may be able to join
- Patients must meet the following inclusion criteria to participate in this study:
- Female ≥ 18 years old.
- Patients have undergone a single or double mastectomy, followed by AlloMend® Acellular Dermal Matrix -assisted, pre-pectoral breast reconstruction.
- Patients have undergone either one-stage (direct-to-implant) or two-stage (expander-to-implant), unilateral or bilateral pre-pectoral breast reconstruction using AlloMend®.
Who cannot join
- Patients must not meet any of the following criteria to be considered for this clinical trial:
- Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
- Did not have post-operative evaluations at the clinical site.
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: A Study to Evaluate the Safety and Effectiveness of AlloMend® Acellular Dermal Matrix Used in Post Mastectomy Pre-Pectoral Breast Reconstruction and Followed for Up To 12-Months Post-Operatively
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
Read the detailed description
AlloMend® Acellular Dermal Matrix AlloMend® is a sterile, ready-to-use, human-derived acellular dermal matrix (ADM) allograft that can be used in a number of reconstructive and other surgical procedures. It is made from donated human full-thickness skin. After the epidermal and hypodermal layers are removed, the tissue is treated by a proprietary cleansing process.
AlloMend® is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy, unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older. AlloMend® may be used in either one-stage (direct-to-implant) or two-stage (expander-to-implant) procedures.
This retrospective study will be performed at one center in the United States.
Information from the preoperative clinical visit and Pre-Pectoral Breast Reconstruction surgery utilizing AlloMend® Acellular Dermal Matrix allograft, approximately 200 breasts (and up to 100 patients), and the follow-up clinical visits at approximately 2 weeks, 6 weeks, 3 months, 6 months, and 12 months, including clinical assessments, imaging, and patient-reported outcomes, will be collected.
- Being tested
- AlloMend® Acellular Dermal Matrix allograft
- Keywords
- AlloMend, Acellular Dermal Matrix, Pre-pectoral Breast Reconstruction, Allografts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloMend® Acellular Dermal Matrix allograftOther
AlloSource, a non-profit supplier of allografts and one of the nation's leading tissue banks, introduced AlloMend® Acellular Dermal Matrix allograft to bring the benefits of regenerative medicine to more patients. cellular allograft matrices, unlike synthetic materials or xenografts, are recognized as human tissue by the body for graft incorporation by the recipient, minimizing the risk of inflammation or rejection. AlloMend® Acellular Dermal Matrix allograft has been shown to incorporate into the surgical site and demonstrates blood vessel infiltration.
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend®
This primary outcome measure will retrospectively collect descriptive data on patients who have undergone single or double mastectomy followed by pre-pectoral breast reconstruction using AlloMend® Acellular Dermal Matrix allograft. Data will be extracted from medical records and will include patient demographics, medical history, surgical techniques, intraoperative and postoperative complications, prescribed medications, and adjuvant treatments such as chemotherapy and radiation. The objective is to characterize patient profiles, surgical outcomes, and potential complications associated with this reconstructive approach.
Measured: Up to 12-month post-operatively
Secondary outcomes (2)
Retrospective Evaluation of Follow-Up Clinical, Imaging, and Surgical Outcomes
This outcome measure will retrospectively assess post-treatment follow-up data, including physical examinations, imaging findings, physical therapy progress, and the incidence of revision surgery. Data will be extracted from patient records to evaluate recovery progress, functional improvements, and any complications or need for additional interventions.
Measured: Up to 12-month post-operatively
Retrospective Assessment of Patient-Reported Health Status and Quality of Life
This outcome measure will retrospectively evaluate patients' self-reported overall health status and quality of life following surgical intervention. Data will be collected from existing medical records, including patient-reported responses and clinical interviews, to assess perceived well-being, functional limitations, pain levels, and overall satisfaction with treatment outcomes. No specific tool was used to gather their responses.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start27 Jan 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Pectoral Breast Reconstruction Following MastectomyStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlloSource
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853964
- Sponsor's protocol ID
- ADM2024-001
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2024
- 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
- A Study to Evaluate the Safety and Effectiveness of AlloMend® Acellular Dermal Matrix Used in Post Mastectomy Pre-Pectoral Breast Reconstruction and Followed for Up To 12-Months Post-Operatively
- ClinicalTrials.gov ID
- NCT06853964
- Acronym / sponsor ID
- ADM2024-001
- Keywords
- AlloMend, Acellular Dermal Matrix, Pre-pectoral Breast Reconstruction, Allografts
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AlloSourceIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Mar 2025 (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 retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
Detailed description
AlloMend® Acellular Dermal Matrix AlloMend® is a sterile, ready-to-use, human-derived acellular dermal matrix (ADM) allograft that can be used in a number of reconstructive and other surgical procedures. It is made from donated human full-thickness skin. After the epidermal and hypodermal layers are removed, the tissue is treated by a proprietary cleansing process.
AlloMend® is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy, unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older. AlloMend® may be used in either one-stage (direct-to-implant) or two-stage (expander-to-implant) procedures.
This retrospective study will be performed at one center in the United States.
Information from the preoperative clinical visit and Pre-Pectoral Breast Reconstruction surgery utilizing AlloMend® Acellular Dermal Matrix allograft, approximately 200 breasts (and up to 100 patients), and the follow-up clinical visits at approximately 2 weeks, 6 weeks, 3 months, 6 months, and 12 months, including clinical assessments, imaging, and patient-reported outcomes, will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who require a single or double mastectomy and have undergone Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.
Key inclusion criteria (4 listed)
- Female ≥ 18 years old.
- Patients have undergone a single or double mastectomy, followed by AlloMend® Acellular Dermal Matrix -assisted, pre-pectoral breast reconstruction.
- Patients have undergone either one-stage (direct-to-implant) or two-stage (expander-to-implant), unilateral or bilateral pre-pectoral breast reconstruction using AlloMend®.
Key exclusion criteria (3 listed)
- Patients must not meet any of the following criteria to be considered for this clinical trial:
- Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
- Did not have post-operative evaluations at the clinical site.
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 |
|---|---|---|
| AlloMend® Acellular Dermal Matrix allograftAlloSource, a non-profit supplier of allografts and one of the nation's leading tissue banks, introduced AlloMend® Acellular Dermal Matrix allograft to bring the benefits of regenerative medicine to more patients. cellular allograft matrices, unlike synthetic materials or xenografts, are recognized as human tissue by the body for graft incorporation by the recipient, minimizing the risk of inflammation or rejection. AlloMend® Acellular Dermal Matrix allograft has been shown to incorporate into the surgical site and demonstrates blood vessel infiltration. | Other | – |
Primary outcome
Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend®
Time frame: Up to 12-month post-operatively
This primary outcome measure will retrospectively collect descriptive data on patients who have undergone single or double mastectomy followed by pre-pectoral breast reconstruction using AlloMend® Acellular Dermal Matrix allograft. Data will be extracted from medical records and will include patient demographics, medical history, surgical techniques, intraoperative and postoperative complications, prescribed medications, and adjuvant treatments such as chemotherapy and radiation. The objective is to characterize patient profiles, surgical outcomes, and potential complications associated with this reconstructive approach.
2 secondary outcomes
Retrospective Evaluation of Follow-Up Clinical, Imaging, and Surgical Outcomes
Time frame: Up to 12-month post-operatively
Retrospective Assessment of Patient-Reported Health Status and Quality of Life
Time frame: Up to 12 months
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
Related trials for Pre-Pectoral Breast Reconstruction Following Mastectomy
RecruitingObservational study
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
Active, not recruiting
Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
Breast Reconstruction, Implant-Based Breast Reconstruction (IBBR)
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 Pre-Pectoral Breast Reconstruction Following Mastectomy, 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 3 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?
Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend® (time frame: Up to 12-month post-operatively). 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.