JPRN-jRCT1031220718招募中2 期
Incidence of Surgical Site Infection with or without Postoperative Antibiotics in Dermatologic Surgery (SSI-PADS): an open-label, randomized, parallel-group study - SSI-PADS Study
Yoshizaki Ayumi0 个研究点目标入组 700 人开始时间: 2023年3月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Those with benign or malignant lesions of the skin or subcutaneous adipose tissue of the head and neck, trunk, extremities, or limbs.
- •2. Those with a lesion whose incision line is considered to be less than 6 cm.
- •3. Those who undergo surgery under local anesthesia and whose reconstructive procedure is either post excisional open treatment or suture with the intention of scar healing.
- •4. Age: 18 years of age or older at the time consent is obtained.
- •5. Male or female.
- •6. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study.
- •7. Those who can make outpatient visits in accordance with the research implementation schedule.
排除标准
- •1. Those who have taken topical, oral, or intravenous antibiotics to the planned surgical site within 48 hours prior to the surgery.
- •2. Those subjects whose lesions to be resected are infected wounds; those who perform skin grafting and skin flap creation; those who have lesions scheduled for resection in the mucous membranes such as the oral cavity or the genital area.
- •3. Those who are allergic to antiseptics, beta-lactam antibiotics, petroleum jelly, acetaminophen, loxoprofen.
- •4. Those with prosthetic valve, history of endocarditis, congenital heart disease, heart transplantation, valvular repair* within the past 6 months after.
- •*Exclude mitral valve prolapse, rheumatic heart disease, bicuspid valve disease, and calcified aortic stenosis.
- •5. Those undergoing surgery that requires placement of a drain.
- •6. Those with infectious diseases requiring systemic treatment.
- •7. Those with a fever of 38.0 degrees Celsius or higher at the time of registration.
- •8. Those within 2 years of artificial joint surgery.
- •9. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
- •10. Those on immunosuppressive drugs after solid organ or bone marrow transplantation, tthose with congenital immunodeficiency syndrome, and AIDS patients.
- •11. Those who cannot take capsules orally (e.g., during tube feeding or central intravenous nutrition).
- •12. Those with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
- •13. Those with poorly controlled diabetes mellitus (mean HbA1c 8.5 or higher for 3 months before surgery) or hypertension (not excluded if controlled with medication).
- •14. Those with unstable angina (angina with onset or worsening attacks within the last 3 weeks) or a history of myocardial infarction within 6 months.
- •15. Those with a major predisposition to bleeding (not considered a predisposition to bleeding in the following cases: taking antiplatelet agents, taking warfarin with INR<3, or using other anticoagulants).
- •16. Others who are judged inappropriate for participation in this study by the investigator or co-investigator.
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