A randomized, prospective, comparative study to evaluate the efficacy and safety of diced ADM alone use versus combined use of diced ADM and micronized ADM filler for reconstruction of defect areas after breast conserving surgery in breast cancer patients

Kosin University Gospel Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新: 2023年6月26日

适应症

试验速览

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•All subjects can participate in the clinical trial only when all of the following criteria are met.
•? Those between the ages of 20 to under 65 years
•? Subject who will be get a breast partial resection for breast cancer
•? Subject who will be get a oncoplastic breast-conserving surgery using diced MegaDerm® or a combination of diced MegaDerm® and MegaFill® (micronized ADM filler)

•If any of the following items apply, the subject is excluded from the clinical trial.
•Subject who have undergone radiation therapy before surgery
•Subject who will be get a radiation therapy after surgery
•Subject who will be get an additional breast surgery due to local recurrence after breast conserving surgery
•Subject who have an uncontrolled seriously infection
•Subject who have autoimmune diseases
•Subject with blood clotting disorders
•Subject who are judged by medical investigator to be considered unsuitable for this clinical trial

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