A Retrospective Breast Reconstruction Study

February 13, 2024 updated by: Aziyo Biologics, Inc.

A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction

To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.

A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.

Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.

Study Type

Observational

Enrollment (Actual)

223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
        • Baptist Medical Center South
      • Muscle Shoals, Alabama, United States, 35661
        • Shoals Plastic Surgery
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tierney Plastic Surgery
    • Texas
      • Austin, Texas, United States, 78731
        • Ascension/Seton Institute of Reconstructive Plastic Surgery
      • McAllen, Texas, United States, 78504
        • DHR Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of up to 300 female patients, who had direct to implant or two-stage immediate breast reconstruction following unilateral or bilateral mastectomy surgery.

Description

Inclusion Criteria:

  • Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
  • HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.

Exclusion Criteria:

  • Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
  • Female patient who underwent delayed breast reconstruction procedure.
  • Female patient who underwent revision of previous breast reconstruction procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SimpliDerm HADM
Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure.
Other: SimpliDerm HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
AlloDerm HADM
Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure.
Other: AlloDerm HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
AlloMax HADM
Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure.
Other: AlloMax HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
FlexHD HADM
Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure.
Other: FlexHD HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
DermACELL HADM
Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure.
Other: DermACELL HADM
Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Events
Time Frame: From date of surgery through study completion, an average of 9 months
Occurrence of: infection, hematoma, seroma, capsular contracture, mastectomy skin flap dehiscence, mastectomy skin flap necrosis, expander/implant explantation, red breast syndrome, subsequent surgical interventions related to the breast reconstruction process
From date of surgery through study completion, an average of 9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Integration Assessment
Time Frame: From date of surgery through study completion, an average of 9 months
Integration assessment for patients with two-stage reconstruction at time of exchange, if available, via surgeon's operative notes
From date of surgery through study completion, an average of 9 months
Drain Removal
Time Frame: From date of surgery through study completion, an average of 9 months
Time to drain removal and volume of fluid drained, if available
From date of surgery through study completion, an average of 9 months
Intraoperative fill volume
Time Frame: From date of surgery through study completion, an average of 9 months
Intraoperative fill volume
From date of surgery through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aziyo Biologics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Actual)

March 14, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CLP-0004

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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