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NCT Number: NCT06555692

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Female Breast Reconstruction

Age range

20 year–69 year

Sex eligibility

Female

Study type

Observational

Primary location

Soon Chun Hyang University Hospital

Seoul, 04401, South Korea

About this study

In South Korea, breast reconstruction using implants or autologous abdominal tissue is commonly performed to address the aesthetic and psychological needs of patients who have undergone total mastectomy for breast cancer. In such procedures, acellular dermal matrix (ADM) is used to compensate for soft tissue and skin deficits resulting from tumor resection.

This clinical study is designed to evaluate differences in clinical efficacy, aesthetic outcomes, and safety between ADM processed using supercritical carbon dioxide technology and conventional ADM products in breast reconstruction surgery.

The test group will prospectively enroll 60 patients undergoing breast reconstruction using SC Derm (an investigational ADM processed with supercritical carbon dioxide technology). The control group will retrospectively include 60 patients who underwent breast reconstruction using other ADM products, based on medical records from 2022.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transplant acellular dermal matrix(ADM)

Biological

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.

Primary outcomes

  1. Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale

    Time frame: 6 months after surgery

    Cosmetic outcomes will be independently assessed by two qualified specialists based on standardized breast photographs taken preoperatively and at 6 months postoperatively. The evaluation will include breast shape, volume, symmetry, nipple-areolar complex, and scar.

    Each item will be scored using a 5-point Likert scale (1-5), where higher scores indicate better cosmetic outcomes:

    • = Very dissatisfied
    • = Dissatisfied
    • = Neutral
    • = Satisfied
    • = Very satisfied

    The total score ranges from 5 to 25, with higher total scores indicating better overall cosmetic outcomes.

Secondary outcomes

  1. Subject's Satisfaction Assessment

    Time frame: Beaseline to 6 months

    Patient self-assessment of satisfaction with surgical outcomes will be evaluated at 1 month and 6 months postoperatively.

    Satisfaction will be assessed using a 4-point categorical scale (1-4), as follows:

    • = Poor (not satisfied)
    • = Fair (neutral)
    • = Good (satisfied)
    • = Excellent (very satisfied)

    Higher scores indicate greater patient satisfaction.

  2. Baker's grade of capsular contracture

    Time frame: 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

  3. Complication Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

DOF Inc.

Industry

Registry information

Official study title

After Mastectomy in Breast Cancer Patients, Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

Acronym: SCderm

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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