Dermacell ADM Without Basement Membrane
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 9/14/2018 |
| Start Date: | September 1, 2018 |
| End Date: | May 1, 2021 |
| Contact: | Patrick Cottler, PhD |
| Email: | psc5d@virginia.edu |
| Phone: | 434-243-6899 |
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Patrick Cottler, PhD
Phone: 434-243-6899
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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