Clinical trial NCT06555692: Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Breast Reconstruction
Keywords: Acellular Dermal Matrix(ADM)
Breast Reconstruction using implants and ADM
Lead sponsor: DOF Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients who have undergone total mastectomy due to breast cancer from three primary university hospitals.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Subject's Satisfaction Assessment
timeFrame: Beaseline to 6 months
measure: Baker's grade of capsular contracture
timeFrame: 6 months after surgery
measure: Complication Assessment
timeFrame: from the operation day to 6 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
Study officials:
affiliation: Soon Chun Hyang University
name: Woojin Song, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: