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Prospective study to evaluate the protective effect of BellaCell acellular dermal matrix from radiation therapy in prosthetic breast reconstruction

Status Approved

First Submitted Date

2021/02/16
Registered Date

2021/02/23
Last Updated Date

2023/06/28

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005935
Unique Protocol ID	S2021-0254-0001
Public/Brief Title	Prospective study to evaluate the protective effect of BellaCell acellular dermal matrix from radiation therapy in prosthetic breast reconstruction
Scientific Title	Prospective study to evaluate the protective effect of BellaCell acellular dermal matrix from radiation therapy in prosthetic breast reconstruction
Acronym	PBC
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	S2021-0254-0001
Approval Date	2021-02-08
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Um Sub
Title	Professor
Telephone	+82-2-3101-3600
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Contact Person for Public Queries
Name	Hyun Ho
Title	Professor
Telephone	+82-2-3010-5914
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Contact Person for Updating Information
Name	Um Sub
Title	Professor
Telephone	+82-2-3101-3600
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-10-18 Actual
Target Number of Participant	80
Primary Completion Date	2024-02-28 , Anticipated
Study Completion Date	2024-02-28 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2021-10-18 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Hans Biomed Corporation
Organization Type	Others
Project ID	S2021-0254-0001

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Prospective study to evaluate the protective effect of BellaCell acellular dermal matrix from radiation therapy in prosthetic breast reconstruction

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	/Procedure/Surgery
Intervention Description	Among patients scheduled for total mastectomy, patients who visited the outpatient clinic and decided to undergo implant-based breast reconstruction, who wish to participate in this study. The intervention group is divided into Arm I (acellular allogeneic dermis including basement membrane-Megaderm HD) and Arm II (acellular allogeneic dermis without basement membrane-Megaderm Flex HD). All of them use L&C Bio's Megaderm®, which has been approved by the Korean Food and Drug Administration and is commercially available. Number of test subjects: 30 people each for Arm I and Arm II, and a total of 60 people are selected, and Arms are allocated based on random number table extraction and random number table using Microsoft Excel. Prepectoral Breast Reconstruction is the principle of surgery, and the implant is completely wrapped with cell-free alloderm, inserted into the breast, and fixed to the underlying muscles or surrounding tissues depending on the situation. Subjects are not aware of the type of cell-free allogeneic dermis during the clinical trial period. The implant uses Hans Bio's Velazel, and the shape of the surface is the currently commercially available smooth or smooth fine implant. After surgery, a drainage tube is inserted before suturing. In order to confirm the postoperative course and complications, observations are made in the outpatient clinic in the same manner as the protocol for visiting the outpatient clinic of our plastic surgery clinic after breast reconstruction with the existing implant. Observe the course at 2 weeks, 1 month, 3 months, 6 months, and 1 year after surgery.
Number of Arms	2
Arm 1	Arm Label Cell-free allogeneic dermis
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description The intervention group is divided into Arm I (acellular allogeneic dermis including basement membrane-Megaderm HD) and Arm II (acellular allogeneic dermis without basement membrane-Megaderm Flex HD).
Arm 2	Arm Label Cell-free allogeneic dermis
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description The intervention group is divided into Arm I (acellular allogeneic dermis including basement membrane-Megaderm HD) and Arm II (acellular allogeneic dermis without basement membrane-Megaderm Flex HD).

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (Z00-Z99)Factors influencing health status and contact with health services (Z42.1)Persons encountering health services for follow-up care involving plastic surgery of breast Underlying disease, smoking, chemotherapy
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~80Year
	Description Breast cancer patients aged 20 years or older and under 80 years of age who undergo breast reconstruction immediately after total mastectomy
Exclusion Criteria	1) Those who have previously had mastectomy, breast augmentation, or breast reconstruction 2) When both breasts are performed at the same time or when the opposite side is performed 3) When inserting an expander 4) Patients who have undergone organ transplant and are taking immunosuppressants 5) Those whose mental state may affect the progress of clinical trials due to alcohol and drug abuse 6) Those who are unable to conduct the survey conducted in this clinical trial 7) Those who participated in other clinical trials within 120 days before screening 8) When other investigators determine that it is inappropriate for this clinical trial
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Postoperative chemotherapy and radiation therapy
Timepoint	120 days Within after surgery
Secondary Outcome(s) 1
Outcome	Vital sign (Blood pressure, pulse, body temperature)
Timepoint	120 days Within after surgery
Secondary Outcome(s) 2
Outcome	Adverse effect(Previous abdominal resection, augmentation, reconstruction, dilator insertion, organ transplantation, taking immunosuppressants, alcohol and drug abuse, etc.)
Timepoint	120 days Within after surgery
Secondary Outcome(s) 3
Outcome	Breast reconstruction surgery
Timepoint	120 daysWithin after surgery
Secondary Outcome(s) 4
Outcome	Evaluate the progress of surgery and the presence of complications
Timepoint	2 weeks, 1 month, 3 months, 6 months, 12 months after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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