Breast CancerNCT04060134
A Retrospective Breast Reconstruction Study
An observational study of Breast Cancer, run by Elutia Inc. at 5 sites in United States.
Trial summary
To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SimpliDerm HADM, AlloDerm HADM and AlloMax HADM
- How many people
- 223 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Nov 2019to 1 Jun 2022
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of up to 300 female patients, who had direct to implant or two-stage immediate breast reconstruction following unilateral or bilateral mastectomy surgery.
Who may be able to join
- Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
- HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.
Who cannot join
- Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
- Female patient who underwent delayed breast reconstruction procedure.
- Female patient who underwent revision of previous breast reconstruction procedure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ascension/Seton Institute of Reconstructive Plastic Surgery
Austin, Texas, 78731
DHR Health
McAllen, Texas, 78504
Baptist Medical Center South
Montgomery, Alabama, 36116
Shoals Plastic Surgery
Muscle Shoals, Alabama, 35661
Tierney Plastic Surgery
Nashville, Tennessee, 37203
About this study
Official title: A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction
To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
Read the detailed description
This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.
A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.
Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.
- Conditions
- Breast Cancer
- Being tested
- SimpliDerm HADM, AlloDerm HADM, AlloMax HADM, FlexHD HADM, DermACELL HADM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimpliDerm HADMOther
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
AlloDerm HADMOther
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
AlloMax HADMOther
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
FlexHD HADMOther
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
DermACELL HADMOther
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
| Study group | Role | What they receive |
|---|---|---|
| SimpliDerm HADM | Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure. Receives: Other: SimpliDerm HADM | |
| AlloDerm HADM | Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure. Receives: Other: AlloDerm HADM | |
| AlloMax HADM | Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure. Receives: Other: AlloMax HADM | |
| FlexHD HADM | Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure. Receives: Other: FlexHD HADM | |
| DermACELL HADM | Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure. Receives: Other: DermACELL HADM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Events
Occurrence of: infection, hematoma, seroma, capsular contracture, mastectomy skin flap dehiscence, mastectomy skin flap necrosis, expander/implant explantation, red breast syndrome, subsequent surgical interventions related to the breast reconstruction process
Measured: From date of surgery through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start20 Nov 2019
- Primary completion14 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Retrospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060134
- Sponsor's protocol ID
- CLP-0004
- Status last verified
- Feb 2024
- First submitted
- 12 Aug 2019
- Last updated
- 14 Feb 2024
- 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 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04060134
- Acronym / sponsor ID
- CLP-0004
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 16 Aug 2019 (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 collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
Detailed description
This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.
A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.
Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SimpliDerm HADM | – | Other: SimpliDerm HADMPatients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure. |
| AlloDerm HADM | – | Other: AlloDerm HADMPatients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure. |
| AlloMax HADM | – | Other: AlloMax HADMPatients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure. |
| FlexHD HADM | – | Other: FlexHD HADMPatients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure. |
| DermACELL HADM | – | Other: DermACELL HADMPatients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of up to 300 female patients, who had direct to implant or two-stage immediate breast reconstruction following unilateral or bilateral mastectomy surgery.
Key inclusion criteria (2 listed)
- Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
- HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.
Key exclusion criteria (3 listed)
- Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
- Female patient who underwent delayed breast reconstruction procedure.
- Female patient who underwent revision of previous breast reconstruction procedure.
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 |
|---|---|---|
| SimpliDerm HADMHuman acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. | Other | SimpliDerm HADM |
| AlloDerm HADMHuman acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. | Other | AlloDerm HADM |
| AlloMax HADMHuman acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. | Other | AlloMax HADM |
| FlexHD HADMHuman acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. | Other | FlexHD HADM |
| DermACELL HADMHuman acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. | Other | DermACELL HADM |
Primary outcome
Occurrence of Events
Time frame: From date of surgery through study completion, an average of 9 months
Occurrence of: infection, hematoma, seroma, capsular contracture, mastectomy skin flap dehiscence, mastectomy skin flap necrosis, expander/implant explantation, red breast syndrome, subsequent surgical interventions related to the breast reconstruction process
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Aziyo Biologics, Inc.Link provided by the sponsor.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Elutia Inc. at 5 sites 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 2 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: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of Events (time frame: From date of surgery through study completion, an average of 9 months). 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 Feb 2024.