Evaluation of ADM Soft Tissue Reinforcement

NCT03494244 | Unknown FDA Device

• 1 other identifier: 2018P000084
• Study Type: observational
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of acellular dermal matrix (ADM) has facilitated implant-based breast reconstruction, both in single-stage direct-to-implant (DTI) and staged tissue expander placement. Nearly half of all breast reconstruction procedures performed within the United States have incorporated ADM. Despite such widespread acceptance among both patients and plastic surgeons, manufacturers of ADM face difficulties in obtaining approval by the Food and Drug Administration (FDA) for use of their product as a medical device in breast reconstructions. ADM is defined as banked tissue and, as such, is approved for use as tissue support. Under section 510k of the Food, Drug and Cosmetic Act, ADM must exhibit "soft tissue reinforcement of integument" to be considered a medical device, a criterion that has yet to be physiologically or clinically defined. This distinction precludes the development and manufacture of xenogeneic ADM. The aim of this research is to compare reconstruction outcomes between ADM and Vicryl, a non-ADM control that is hydrolyzed and degraded within 6-8 weeks after surgery. The investigators propose a prospective cohort study to determine whether post-operative outcomes provide clinical and anatomic evidence for soft tissue reinforcement within the ADM group.

Conditions

Breast Cancer; Surgery; Surgical Item, Retained

Keywords

acellular dermal matrix; breast reconstruction; efficacy

Outcome Measures

Primary Outcomes (2)

• Change in Tissue thickness (measured in millimeters).

  Anatomic measurement of mastectomy skin flap thickness will be conducted comparing ADM and Vicryl patient cohorts. Breast skin flap thickness will be measured at landmarks reproducible over time and comparable between patients. We will determine tissue thickness in the following areas: (a) point of maximal projection, (b) the midpoint between maximal projection and the inferior pole of the breast, and (c) the inferior pole of the breast. During measurement, patients will be positioned upright, such that gravitational force will be exerted on the breast skin flap by the prosthesis. Tissue thickness will be determined via transcutaneous ultrasound (GE NextGen LOGIQ e R7 compact digital ultrasound). The mastectomy skin flap will be defined as the tissue between the air-skin interface to the deep margin of the subcutaneous layer. Tissue thickness, in millimeters (mm), will be calculated using a predetermined prediction algorithm.

  Post-surgical, follow-up intervals extending to one year following reconstruction. Measurements will be performed at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.

• Change in Anatomic landmark position (measured in centimeters)

  Thoracoabdominal images will be captured using Vectra 3M, a three-dimensional imaging (TDI) system commonly used to evaluate anatomical parameters of breast form and volume. This study uniquely employs TDI to evaluate the position of breast landmarks over time to objectively assess ptosis following ADM and non- ADM-based breast reconstructions. The following breast landmarks will be identified using a Vectra algorithm and confirmed by a trained medical assistant: sternal notch (Sn), nipple (N), and inframammary fold (IMF). Breast ptosis, defined as depression of breast tissue with respect to the IMF, will be objectively assessed as the relative position of nipple to the inferior margin. Changes in Sn-IMF and N-IMF lengths will be normalized across implant size. This will provide an indication of the amount of breast ptosis experienced by ADM and non-ADM cohorts per unit volume of prosthesis.

  Post-surgical, follow-up intervals extending to one year following reconstruction. These cardinal landmarks of breast form and axis length will be collected at the following intervals, post-operatively: 6 weeks, 3 months, 6 months, 12 months.

Secondary Outcomes (2)

• Infection

  90 days post-operatively.

• Self reported outcomes

  Post-surgical, follow-up intervals extending to one year following reconstruction.

Study Arms (2)

ADM

Patients having undergone direct-to-implant breast reconstruction using acellular dermal matrix.

Procedure: Direct-to-implant breast reconstruction; Device: Acellular dermal matrix

Non-ADM (Vicryl)

Patients having undergone direct-to-implant breast reconstruction using non-acellular dermal matrix mesh (Vicryl mesh).

Procedure: Direct-to-implant breast reconstruction

Interventions

Direct-to-implant breast reconstruction PROCEDURE

Terminal prosthetic implanted at the time of mastectomy.

Also known as: DTI

ADM; Non-ADM (Vicryl)

Acellular dermal matrix DEVICE

Banked tissue used to support the directly implanted breast prosthesis.

Also known as: ADM

ADM

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who undergo breast reconstruction if they have mastectomies for the purpose of either removing breast cancer or prophylactic removal of the breasts following diagnosis of genetic predisposition for breast cancer based on family history or genetic testing

You may qualify if:

• direct to implant breast reconstruction

You may not qualify if:

• BMI \> 30
• history of smoking within 1 year of enrollment
• previous breast surgery
• malnutrition or cachexia
• breast implant volume ≤ 125 mL or ≥ 700 mL

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Foreign Bodies

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Eric Liao, MD, PhD

CONTACT

6176435975; cliao@partners.org

Nikhil Sobti

CONTACT

7326181701; nsobti@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor or Surgery, Division of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: April 11, 2018
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share