Recruiting

Dermacell ADM

Sponsor:

University of Virginia

Code:

NCT03667560

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dermacell ADM without basement membrane

FlexHD

Study Details

Brief 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 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

Study ID

NCT03667560

Start date

Sep 1, 2018

Status verified date

Sep, 2018

Completion date

May 1, 2021

Anticipated

Primary completion date

May 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dermacell ADM without basement membrane

Dermacell ADM without a basement membrane

active comparator: FlexHD

FDA-approved FlexHD Pliable

Interventions

Dermacell ADM without basement membrane

Patient will be implanted with Dermacell ADM.

FlexHD

Patient will be implanted with FlexHD.

Primary outcome measure

  • Seroma Formation [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Patrick Cottler, PhD

434-243-6899psc5d@virginia.edu

Dena Snyder, RN

434-243-6899ds6he@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Dena Snyder, RN-BSN

434-243-6899ds6he@virginia.edu

Principal Investigator:

Patrick Cottler, PhD

More Information

Sponsor

University of Virginia

Last update posted

Sep 12, 2018

Last verified

Sep, 2018

Keywords

  • Mastectomy
  • Breast Reconstruction
  • Acellular dermal matrix

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2018-09-12.