A Retrospective Breast Reconstruction Study

• Sponsor: Aziyo Biologics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04060134
• Collaborator: (none)
• Enrollment: 223
• Locations: 5
• Actual Duration (Months): 30.4
• Patients Per Site: 44.6
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: SimpliDerm HADM; Other: AlloDerm HADM; Other: AlloMax HADM; Other: FlexHD HADM; Other: DermACELL HADM

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 Design

• Study Type: Observational
• Actual Enrollment: 223 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction
• Actual Study Start Date: Nov 20, 2019
• Actual Primary Completion Date: Mar 14, 2022
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

Other Outcome Measures

1. Integration Assessment [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 [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 [From date of surgery through study completion, an average of 9 months]

   Intraoperative fill volume

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Medical Center South	Montgomery	Alabama	United States	36116
2	Shoals Plastic Surgery	Muscle Shoals	Alabama	United States	35661
3	Tierney Plastic Surgery	Nashville	Tennessee	United States	37203
4	Ascension/Seton Institute of Reconstructive Plastic Surgery	Austin	Texas	United States	78731
5	DHR Health	McAllen	Texas	United States	78504

Sponsors and Collaborators

• Aziyo Biologics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Aziyo Biologics, Inc.

Publications

None provided.

• Responsible Party: Aziyo Biologics, Inc.
• ClinicalTrials.gov Identifier: NCT04060134
• Other Study ID Numbers: CLP-0004
• First Posted: Aug 16, 2019
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 8, 2022