A Retrospective Breast Reconstruction Study

Completed

• Conditions: Breast Cancer
• Interventions: Other: SimpliDerm HADM; Other: DermACELL HADM; Other: AlloDerm HADM; Other: AlloMax HADM; Other: FlexHD HADM

• Registration Number: NCT04060134
• Lead Sponsor: Aziyo Biologics, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Study Start: 2019-11-20
• Primary Completion: 2022-03-14
• Study Completion: 2022-06-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SimpliDerm HADM	SimpliDerm HADM	Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure.
DermACELL HADM	DermACELL HADM	Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure.
AlloDerm HADM	AlloDerm HADM	Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure.
AlloMax HADM	AlloMax HADM	Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure.
FlexHD HADM	FlexHD HADM	Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure.

Primary Outcome Measures

Name	Time	Method
Occurrence of Events	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

Trial Locations

Locations (5)

DHR Health; 🇺🇸 McAllen, Texas, United States

Baptist Medical Center South; 🇺🇸 Montgomery, Alabama, United States

Shoals Plastic Surgery; 🇺🇸 Muscle Shoals, Alabama, United States

Tierney Plastic Surgery; 🇺🇸 Nashville, Tennessee, United States

Ascension/Seton Institute of Reconstructive Plastic Surgery; 🇺🇸 Austin, Texas, United States