Breast Cancer Female, Breast Reconstruction
Conditions
Keywords
Acellular Dermal Matrix(ADM), Breast Reconstruction using implants and ADM
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALTransplant 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
DOF Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale | 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: 1. = Very dissatisfied 2. = Dissatisfied 3. = Neutral 4. = Satisfied 5. = Very satisfied The total score ranges from 5 to 25, with higher total scores indicating better overall cosmetic outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Satisfaction Assessment | 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: 1. = Poor (not satisfied) 2. = Fair (neutral) 3. = Good (satisfied) 4. = Excellent (very satisfied) Higher scores indicate greater patient satisfaction. |
| 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 |
| 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORWoojin Song, Ph.D
Soon Chun Hyang University
Outcome results
None listed