NCT03145337

Brief Summary

Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two allograft dermal matrices (ADMs) currently in use for tissue assisted immediate post-mastectomy breast reconstruction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

September 19, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

May 3, 2017

Last Update Submit

September 18, 2018

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Post Reconstruction Complication Rates

    To compare the overall complication rate between the cohorts defined as either 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention, 2) seroma, and/or 3) reconstructive failure

    12 months

Secondary Outcomes (2)

  • Comparison of Each Complication Rate

    12 months

  • Comparison of Aesthetic Outcomes (Photographs)

    12 months

Study Arms (2)

Cohort A

ACTIVE COMPARATOR

FlexHD ADM

Biological: FlexHD ADM (Cohort A)

Cohort B

ACTIVE COMPARATOR

AlloDerm RTU ADM

Biological: AlloDerm RTU ADM (Cohort B)

Interventions

FlexHD ADM (Cohort A)BIOLOGICAL

Tissue assisted breast reconstruction with FlexHD pliable perforated ADM

Also known as: FlexHD ADM
Cohort A
AlloDerm RTU ADM (Cohort B)BIOLOGICAL

Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM

Also known as: AlloDerm RTU ADM
Cohort B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to undergo immediate, post-mastectomy, tissue assisted breast reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or two-stage, unilateral or bilateral, prophylactic or therapeutic
  • Females at least 18 years of age
  • Non-smokers, former smokers and/or smokers who have not smoked within 1 month before surgery, and who agree to not smoke or utilize e-cigarettes during the post-operative period
  • Have signed a written informed consent
  • Have the ability to understand and comply with the requirements and follow-up time points of the study

You may not qualify if:

  • Previous breast surgery with the exception of biopsy
  • Previous radiation treatment in either breast at any time
  • Undergoing autologous breast reconstruction
  • Pre-pectoral implant placement
  • Undergoing delayed reconstruction
  • Requiring Wise pattern reduction of mastectomy skin flap
  • History of chronic steroid use within the past 6 months
  • History of HIV positive
  • Previous organ transplant
  • Pregnant or lactating females
  • Clinically significant systemic disease, as determined by the investigator, which could affect study participation or study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

NorthShore Health Systems

Evanston, Illinois, 60062, United States

Location

Louisiana State Health Science Center

New Orleans, Louisiana, 70115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Faulkner Brigham & Women's Hospital

Jamaica Plain, Massachusetts, 02130, United States

Location

New York University Langone Medical Center

New York, New York, 10017, United States

Location

Harris Methodist Southlake Hospital

Fort Worth, Texas, 76104, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
3-4 independent breast surgeons using predefined criteria will assess the aesthetic outcomes of each subject using photographs of their pre-mastectomy and 12 month post-reconstructions. The surgeons will not be apprised of the ADM type or post-mastectomy site/surgeon
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 9, 2017

Study Start

July 1, 2017

Primary Completion

February 1, 2019

Study Completion

May 1, 2019

Last Updated

September 19, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(7)