Breast CancerNCT03667560
Dermacell ADM Without Basement Membrane
A study testing Dermacell ADM without basement membrane and FlexHD in people with Breast Cancer, run by University of Virginia at 1 site in United States.
Trial summary
DermACELL acellular dermal matrix (D-ADM) is the trade name of LifeNet Health's acellular dermal matrix (ADM). LifeNet Health will remove the basement membrane from the D-ADM and this product will be compared to FlexHD® Pliable, which does not include a basement membrane in order to demonstrate that D-ADM without a… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dermacell ADM without basement membrane and FlexHD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 May 2021
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer
- Candidate for and decide to undergo implant-based reconstruction
- Willing and able to provided written informed consent and comply with the study protocol.
Who cannot join
- Women planning to undergo radiation treatment or whose tumor characteristics of the mastectomy specimen dictate that post-op radiation will be required.
- Women planning to undergo adjuvant chemotherapy.
- Women who have had prior breast cancer treated with breast conservation therapy requiring radiation for the same breast being treated will be excluded.
- Known sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin.
- Women who have the presence of any condition that in the opinion of the investigator places the participant at undue risk or potentially jepordizes the quality of data to be generated.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Dena Snyder, RN-BSN, 434-243-6899, ds6he@virginia.edu
Patrick Cottler, PhD
About this study
Official title: Randomized and Blinded Clinical Evaluation of Dermacell Without Basement Membrane in Breast Reconstruction.
DermACELL acellular dermal matrix (D-ADM) is the trade name of LifeNet Health's acellular dermal matrix (ADM). LifeNet Health will remove the basement membrane from the D-ADM and this product will be compared to FlexHD® Pliable, which does not include a basement membrane in order to demonstrate that D-ADM without a basement membrane is not inferior to FlexHD in the frequency of significant side effects that result from breast implants. This is a post market trial that is comparing two ADM products with a known safety profile. The D-ADM without a basement membrane is being prepared specifically for this UVA evaluation. Removal of the basement membrane by the manufacturer is considered minimal manipulation. D-ADM without a basement membrane will be considered a human cell, tissue, and cellular and tissue-based product (HCT/P) and is eligible for marketing immediately within the US, if desired by LifeNet Health (LNH). Additionally, the applications of the products are indicated. Therefore, the trial is not in support of an Investigational Device Exemption (IDE).
Prior to surgery, the registered subject will be randomized to receive the D-ADM without the basement membrane or the comparator, FlexHD Pliable. The surgeon and the patient will be blinded to the product group. The patient will receive the ADM at the time of placement of the tissue expander. After a period of tissue expansion, the patient will have the expander-implant exchange. During this surgery, there will be 3 punch biopsies taken in 3 different locations: native breast tissue, center of the ADM, and the border of the ADM and subject's breast tissue. These specimens will be analyzed to estimate differences in immunologic and inflammatory response for each ADM product.
The patient will follow up with the surgeon at 1-3 weeks, 3 months, 6 months, 9 months, and 12 months post implant exchange. At these visits, the surgeon will assess for any adverse events and this information will be collected for research purposes. The patient will be asked to complete the reconstruction module of the Breast-Q at the baseline visit and 6 and 12 months to assess quality of life and patient satisfaction.
- Conditions
- Breast Cancer
- Being tested
- Dermacell ADM without basement membrane, FlexHD
- Keywords
- Mastectomy, Breast Reconstruction, Acellular dermal matrix
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermacell ADM without basement membraneProcedure or surgery
Patient will be implanted with Dermacell ADM.
FlexHDProcedure or surgery
Patient will be implanted with FlexHD.
| Study group | Role | What they receive |
|---|---|---|
| Dermacell ADM without basement membrane | Experimental | Dermacell ADM without a basement membrane Receives: Procedure: Dermacell ADM without basement membrane |
| FlexHD | Active comparator | FDA-approved FlexHD Pliable Receives: Procedure: FlexHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma Formation
Determine severity of seroma formation with each arm by observing drainage output and if seroma requires significant surgical intervention.
Measured: 12 months
Secondary outcomes (5)
Capsular Contracture
Estimate the degree of capsular contracture in participants in each study arm by using the Baker Scale.
Grade I-The breast is soft and appears natural in size and shape. Grade II- The breast is slightly firm but appears normal Grade III- The breast is firm and appears abnormal Grade IV- the breast is hard, painful to the touch, and appears abnormal
Measured: 12 months
Red breast syndrome
Estimate the frequency of red breast syndrome among participants on each arm
Measured: 12 months
QOL
Determine patient's quality of life and satisfaction with the reconstruction process. Assessment will be done with the standardized Breast-Q Reconstruction Module.
Measured: 12 months
Infection
Estimate the frequency and degree of infection among patients on each study arm. Infections will be identified by the surgeon and determined to be major or minor. In addition to this, the need for IV s. oral antibiotics and/or further surgery will be used as a measure of degree of infection.
Measured: 12 months
Histological Assessment
Estimate the differences in immunologic and inflammatory responses on each study arm by histological assessment of the capsular and ADM biopsies, including quantity of inflammatory cells, macrophages, and migration/differentiation of myelofibroblasts.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- LifeNet Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667560
- Sponsor's protocol ID
- 20295
- Status last verified
- Sep 2018
- First submitted
- 6 Apr 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Blinded Clinical Evaluation of Dermacell Without Basement Membrane in Breast Reconstruction.
- ClinicalTrials.gov ID
- NCT03667560
- Acronym / sponsor ID
- 20295
- Conditions
- Breast Cancer
- Keywords
- Mastectomy, Breast Reconstruction, Acellular dermal matrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- LifeNet Health
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 12 Sep 2018 (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.
DermACELL acellular dermal matrix (D-ADM) is the trade name of LifeNet Health's acellular dermal matrix (ADM). LifeNet Health will remove the basement membrane from the D-ADM and this product will be compared to FlexHD® Pliable, which does not include a basement membrane in order to demonstrate that D-ADM without a basement membrane is not inferior to FlexHD in the frequency of significant side effects that result from breast implants. This is a post market trial that is comparing two ADM products with a known safety profile. The D-ADM without a basement membrane is being prepared specifically for this UVA evaluation. Removal of the basement membrane by the manufacturer is considered minimal manipulation. D-ADM without a basement membrane will be considered a human cell, tissue, and cellular and tissue-based product (HCT/P) and is eligible for marketing immediately within the US, if desired by LifeNet Health (LNH). Additionally, the applications of the products are indicated. Therefore, the trial is not in support of an Investigational Device Exemption (IDE).
Prior to surgery, the registered subject will be randomized to receive the D-ADM without the basement membrane or the comparator, FlexHD Pliable. The surgeon and the patient will be blinded to the product group. The patient will receive the ADM at the time of placement of the tissue expander. After a period of tissue expansion, the patient will have the expander-implant exchange. During this surgery, there will be 3 punch biopsies taken in 3 different locations: native breast tissue, center of the ADM, and the border of the ADM and subject's breast tissue. These specimens will be analyzed to estimate differences in immunologic and inflammatory response for each ADM product.
The patient will follow up with the surgeon at 1-3 weeks, 3 months, 6 months, 9 months, and 12 months post implant exchange. At these visits, the surgeon will assess for any adverse events and this information will be collected for research purposes. The patient will be asked to complete the reconstruction module of the Breast-Q at the baseline visit and 6 and 12 months to assess quality of life and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermacell ADM without basement membrane | Experimental | Procedure: Dermacell ADM without basement membraneDermacell ADM without a basement membrane |
| FlexHD | Active comparator | Procedure: FlexHDFDA-approved FlexHD Pliable |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer
- Candidate for and decide to undergo implant-based reconstruction
- Willing and able to provided written informed consent and comply with the study protocol.
Key exclusion criteria (5 listed)
- Women planning to undergo radiation treatment or whose tumor characteristics of the mastectomy specimen dictate that post-op radiation will be required.
- Women planning to undergo adjuvant chemotherapy.
- Women who have had prior breast cancer treated with breast conservation therapy requiring radiation for the same breast being treated will be excluded.
- Known sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin.
- Women who have the presence of any condition that in the opinion of the investigator places the participant at undue risk or potentially jepordizes the quality of data to be generated.
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 |
|---|---|---|
| Dermacell ADM without basement membranePatient will be implanted with Dermacell ADM. | Procedure or surgery | Dermacell ADM without basement membrane |
| FlexHDPatient will be implanted with FlexHD. | Procedure or surgery | FlexHD |
Primary outcome
Seroma Formation
Time frame: 12 months
Determine severity of seroma formation with each arm by observing drainage output and if seroma requires significant surgical intervention.
5 secondary outcomes
Capsular Contracture
Time frame: 12 months
Red breast syndrome
Time frame: 12 months
QOL
Time frame: 12 months
Infection
Time frame: 12 months
Histological Assessment
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermacell ADM without basement membrane and FlexHD in people with Breast Cancer, run by University of Virginia 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 3 inclusion and 5 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 12 Sep 2018. 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 Patrick Cottler, PhD (434-243-6899, psc5d@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma Formation (time frame: 12 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 12 Sep 2018.