NCT06555614

Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction

Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: DOF Inc. · Industry
• Sex: Female
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.

Detailed description

Outline: The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group. The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery. The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024. After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks. Primary Objectives I. To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.

Conditions

• Breast Cancer Female
• Breast Reconstruction

Interventions

Type	Name	Description
OTHER	Acellular Dermal Matrix(ADM)	A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.

Timeline

• Start date: 2024-06-13
• Primary completion: 2026-12-31
• Completion: 2027-02-28
• First posted: 2024-08-15
• Last updated: 2024-08-15

Locations

1 site across 1 country: South Korea