Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction

NCT06553859 | Recruiting

• 1 other identifier: 2023-01-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other ADM products that have been washed with detergents. The study will also assess safety outcomes.

Conditions

Breast Cancer Female

Keywords

Breast Reconstruction using Implants and ADM

Outcome Measures

Primary Outcomes (1)

• The number of occurrences of pre-determined expected adverse events and complications

  The number of occurrences of pre-determined expected adverse reactions and complications will be compared between the experimental group and the control group.

  From the day of operation of breast reconstruction to 12 months

Secondary Outcomes (1)

• Subjects' self-assessment of satisfaction with physical and psychological well-being using the BREAST-Q survey

  From the day of operation of breast reconstruction to 12 months

Study Arms (2)

Test Group

Fifty subjects are to be enrolled prospectively. Breast cancer patients who are willing to undergo breast reconstruction surgery based on inserting breast implants with ADM will be selected as the test group, with "SC Derm"(Acellular Dermal Matrix processed by CO2 supercritical fluid technology.)

Other: No intervention conducts.

Control Group

Fifty subjects are to be enrolled retrospectively from the medical records of breast cancer patients who have undergone breast reconstruction surgery based on inserting breast implants with ADM made by other companies. All breast reconstruction surgeries have operated from 1, June 2021 to 9, November 2021 at Asan medical center at Seoul, South Korea.

Interventions

No intervention conducts. OTHER

The type and method of breast reconstruction with sillicon implants and ADM implanting is now the standard treatment of breast cancer in korea. no any specific intervention has occurred during the surgery.

Test Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study is scheduled to include 50 prospective and 50 retrospective subjects. The retrospective recruitment period for subjects is from June 1, 2021 to November 9, 2021. Patients who meet the inclusion criteria will be consecutively selected from patients who underwent breast reconstruction with implants. The basis for calculation of retrospective patients was not statistically calculated, but considering that the number of implant breast reconstruction patients at our hospital is 500 per year, when only patients who completed follow-up for more than 1 year were included, approximately 5-10% were enrolled in the study. This was expected and calculated to be possible.

You may qualify if:

• \. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy

You may not qualify if:

• Patients who have received an organ transplant and are taking any immunosuppressant.
• Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.
• People who are unable to complete the survey conducted in this clinical study.
• Patients who participated in other clinical trials within the previous 120 days at the time of screening.
• If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.

Sponsors & Collaborators

• DOF Inc.: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Related Links

• Mazari FAK, Wattoo GM, Kazzazi NH, et al. The comparison of strattice and surgimend in acellular dermal matrix-assisted, implant-based immediate breast reconstruction. Plast Reconstr Surg 2018;141(2):283-293
• Polotto S, Bergamini ML, Pedrazzi G, et al. One-step prepectoral breast reconstruction with porcine dermal matrix-covered implant: a protective technique improving the outcome in post-mastectomy radiation therapy setting. Gland Surg 2020;9(2):219-228
• Decreased length of postoperative drain use, parental opioids, length of stay and complication rates in patients receiving meshed versus unmeshed acellular dermal matrix in 194 submuscular tissue expander-based breast reconstructions
• Viezel-Mathieu A, Alnaif N, Aljerian A, et al.Acellualr dermal matrix-sparing direct-to-implant prepectoral breast reconstruction: A comparative study including cost analysis. Ann Plast Surg 2020;84(2):139-143
• Nam SY, Youn D, Kim GH, et al. In vitro characterization of a novel human acellular dermal matrix(BellaCell HD) for breast reconstruction. Bioengineering(Basel) 2020;7(2):39.
• Seo Y, Jung Y, Kim SH. Decellularized heart ECM hydrogel using supercritical carbon dioxide for improved angiogenesis. Acta Biomater. 2018;67:270-281

Study Officials

• Jinsup Um

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsup Um

CONTACT

+82 02-3010-3600; jinsupp@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 14, 2024
• Study Start: June 12, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)