Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
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
DOF Inc.
120 participants
Jan 4, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Female patients aged 20 to 69 scheduled for total mastectomy
- Patients who are willing to undergo immediate breast reconstruction using implants.
Exclusion Criteria4
- 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.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06555692