Dermacell ADM Without Basement Membrane

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Dermacell ADM without basement membrane; Procedure: FlexHD

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Cottler, PhD; Phone Number: 434-243-6899; Email: psc5d@virginia.edu
• Study Contact Backup: Name: Dena Snyder, RN; Phone Number: 434-243-6899; Email: ds6he@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Dena Snyder, RN-BSN; Phone Number: 434-243-6899; Email: ds6he@virginia.edu
      • Principal Investigator: Patrick Cottler, PhD
      • Sub-Investigator: Christopher Campbell, MD
      • Sub-Investigator: Jeremy Benedetti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermacell ADM without basement membrane; Dermacell ADM without a basement membrane	Procedure: Dermacell ADM without basement membrane; Patient will be implanted with Dermacell ADM.
Active Comparator: FlexHD; FDA-approved FlexHD Pliable	Procedure: FlexHD; Patient will be implanted with FlexHD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma Formation	Determine severity of seroma formation with each arm by observing drainage output and if seroma requires significant surgical intervention.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
Red breast syndrome	Estimate the frequency of red breast syndrome among participants on each arm	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.	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.	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.	Day 1

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: LifeNet Health

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Mastectomy; Breast Reconstruction; Acellular dermal matrix
• Other Study ID Numbers: 20295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No