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

Recruiting

• Conditions: Breast Cancer Female; Breast Reconstruction
• Interventions: Biological: Transplant acellular dermal matrix(ADM)

• Registration Number: NCT06555692
• Lead Sponsor: DOF Inc.

Brief Summary

This is the multi-centered, open, prospective and retrospective study of up to total 120 subjects in breast reconstruction surgery with applying acellular dermal matrix(ADM). The aim of the study is to ascertain any difference in the rate of complications between the test group of undergoing breast reconstruction with SC Derm and the control group of taking breast reconstruction with other ADM products.

Detailed Description

In South Korea, breast reconstruction surgery using implants or autologous abdominal tissue is commonly performed as the standard treatment to address the aesthetic and psychological needs of breast cancer patients who have undergone total mastectomies. In this procedure, acellular dermal matrix (ADM) is used to compensate for the skin deficit resulting from the removal of cancerous tissue. This clinical study is designed to ascertain whether there are differences in clinical efficacy, aesthetic outcomes, and safety in breast reconstruction surgery using ADM processed with supercritical carbon dioxide technology compared to other ADMs. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology). The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022.

Study Timeline

• Study Start: 2024-01-04
• Status Verified: 2024-05
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Female patients aged 20 to 69 scheduled for total mastectomy
• Patients who are willing to undergo immediate breast reconstruction using implants.

Exclusion Criteria

• Patients who have undergone organ transplantation and are currently taking immunosuppressive medication.
• Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse.
• Patients who have participated in another clinical trial within 120 days prior to screening.
• Any other cases where the investigator deems the patient unsuitable for this clinical study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Transplant acellular dermal matrix(ADM)	The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022. Among patients who underwent implant-based immediate breast reconstruction after total mastectomy, those who had the procedure between January 1, 2022, and December 31, 2022, and who completed at least 6 months of follow-up by June 2023 were included in the study. For this retrospective study, medical records of patients who met the inclusion and exclusion criteria were extracted. Data collection was carried out in the same manner as it would be for a prospective study.
Test Group	Transplant acellular dermal matrix(ADM)	Among patients scheduled for total mastectomy due to the breast cancer, Female patients aged 20 to 69 who are willing to undergo immediate breast reconstruction using implants will be enrolled. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology).

Primary Outcome Measures

Name	Time	Method
Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale	6 months after surgery	Cosmetic outcome evaluation: Independent evaluation by two specialists for breast shape, size, symmetry, nipple position, and scar using standardized breast photos taken before surgery and at 6 months after surgery.; Evaluation: Evaluate the score for each item using a 5 point Likert scale; 1. Shape : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied; 2. Volume : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied; 3. Symmetry : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied; 4. Nipple-areolar Complex : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied; 5. Scar : Very dissatisfied \< Dissatisfied \< Neutral \< Satisfied \< Very Satisfied

Secondary Outcome Measures

Name	Time	Method
Subject's Satisfaction Assessment	Beaseline to 6 months	The patients' self-assessment of their satisfaction with the surgical outcomes at one month and 6 months visit of post-operation.
Complication Assessment	from the operation day to 6 months after surgery	Evaluate the frequency and incidence rate of most commonly occurred complications of infection, skin necrosis, seroma, hematoma, implants removal.
Baker's grade of capsular contracture	6 months after surgery	The occurrence of capsular contracture will be assessed clinically at the same follow-up visits (1 month and 6 months post-surgery).; Grade I: Breast is normally soft and appears natural Grade II: Breast is a little firm but appears normal Grade III: Breast is firm and appears abnormal Grade IV: Breast is hard, painful, and appears abnormal

Trial Locations

Locations (1)

Soon Chun Hyang University Hospital; 🇰🇷 Seoul, Korea, Republic of