Dermacell ADM Without Basement Membrane

NCT03667560 | Unknown DMC

• 1 other identifier: 20295
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Mastectomy; Breast Reconstruction; Acellular dermal matrix

Outcome Measures

Primary Outcomes (1)

• Seroma Formation

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

  12 months

Secondary Outcomes (5)

• Capsular Contracture

  12 months

• Red breast syndrome

  12 months

• QOL

  12 months

• Infection

  12 months

• Histological Assessment

  Day 1

Study Arms (2)

Dermacell ADM without basement membrane

EXPERIMENTAL

Dermacell ADM without a basement membrane

Procedure: Dermacell ADM without basement membrane

FlexHD

ACTIVE COMPARATOR

FDA-approved FlexHD Pliable

Procedure: FlexHD

Interventions

Dermacell ADM without basement membrane PROCEDURE

Patient will be implanted with Dermacell ADM.

Dermacell ADM without basement membrane

FlexHD PROCEDURE

Patient will be implanted with FlexHD.

FlexHD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• LifeNet Health: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FlexHD

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Patrick Cottler, PhD

CONTACT

434-243-6899; psc5d@virginia.edu

Dena Snyder, RN

CONTACT

434-243-6899; ds6he@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: September 12, 2018
• Study Start: September 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)