Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Dermacell ADM without a basement membrane

Patient will be implanted with Dermacell ADM.

Dermacell ADM without basement membrane

FlexHD

Patrick Cottler, PhD

Dena Snyder, RN

Dena Snyder, RN-BSN

Christopher Campbell, MD

Jeremy Benedetti, MD

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.

Dermacell ADM Without Basement Membrane

Randomized and Blinded Clinical Evaluation of Dermacell Without Basement Membrane in Breast Reconstruction.

Determine severity of seroma formation with each arm by observing drainage output and if seroma requires significant surgical intervention.

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

Estimate the frequency of red breast syndrome among participants on each arm

Determine patient's quality of life and satisfaction with the reconstruction process. Assessment will be done with the standardized Breast-Q Reconstruction Module.

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.

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.

LifeNet Health

University of Virginia

Breast Diseases

Skin Diseases

Patients randomly assigned to receive FlexHD for breast reconstruction.

Patients randomly assigned to receive Alloderm for breast reconstruction.

Patients will be randomized to receive FlexHD.

Patient will be randomized to receive Alloderm.

Alloderm

Pallavi A Kumbla, MD

FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction.

FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dermacell ADM Without Basement Membrane	NCT03667560	Breast Cancer	Dermacell ADM w... FlexHD	18 Years - 75 Years	University of Virginia
Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery	NCT02372305	Breast Neoplasm	FlexHD Alloderm	18 Years -	University of Arkansas

Spots Global Cancer Trial Database for flexhd

Every month we try and update this database with for flexhd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for flexhd

Every month we try and update this database with for flexhd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for flexhd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.