Skip to main content
OpenTrials
Completed

NCT Number: NCT04060134

A Retrospective Breast Reconstruction Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Baptist Medical Center South, Montgomery, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SimpliDerm HADM

Other

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

Other

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

Other

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

Other

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

Other

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.

Primary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. Intraoperative fill volume

    Time frame: From date of surgery through study completion, an average of 9 months

    Intraoperative fill volume

Sponsors and collaborators

Lead sponsor

Elutia Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2019
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.