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Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

NCT06555692 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-04-28

No results posted yet for this study

Summary

This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).

The primary objective of this study is to evaluate differences in complication rates between the test group undergoing breast reconstruction with SC Derm and the control group undergoing breast reconstruction with other ADM products.

Conditions

  • Breast Cancer Female
  • Breast Reconstruction

Interventions

BIOLOGICAL

Transplant acellular dermal matrix(ADM)

The principle of surgery is the pectoral muscle preservation (prepectoral) method and the subpectoral method (Breast Reconstruction using implants). After wrapping the implant with acellular dermal matrix(ADM), it is inserted into the breast and fixed to the underlying muscle or surrounding tissue depending on the situation.

Sponsors & Collaborators

  • DOF Inc.

    lead INDUSTRY

Principal Investigators

  • Woojin Song, Ph.D · Soon Chun Hyang University

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-04
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06555692 on ClinicalTrials.gov