CTRI/2022/10/046881招募中4 期
A prospective, randomized, open-label study to compare the efficacy and safety of Sterizone® post-operative silver based wound dressing versus standard gauze dressing in women having elective and emergent caesarean section
Dynamic Techno Medicals Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
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
入选标准
- •Primiparous or multiparous woman aged 18-40 years
- •Woman having gestation between 24(0/7) and 40(6/7) weeks
- •Woman with single or multiple gestations
- •Woman with elective or emergent cesarean deliveries
- •Woman with primary or repeat cesarean sections
- •Woman with Pfannenstiel or low transverse skin incisions
- •Woman with good systemic/mental health as per opinion of the PI
- •Woman with CDC surgical wound classification class I
- •Woman providing written informed consent
排除标准
- •Woman with BMI > 30 Kg/m2
- •Woman with hemoglobin levels < 7g/dL
- •Woman that did not receive routine prophylactic dose of antibiotics in the operating room.
- •Woman with skin incisions other than Pfannenstiel or low transverse incisions
- •Woman requiring more than one incision
- •Woman having urogenital tract infection within 2 weeks before cesarean delivery
- •Woman with known or discovered allergy to suture material or silver
- •Woman with active neoplastic lesion treated with radiation or chemotherapy
- •Woman requiring MRI (Magnetic Resonance Imaging) examination during the course of the study
- •Woman with active skin infection, and coagulopathy
- •Woman prone to develop keloids or have developed keloid with any past surgery
- •Woman taking systemic immunosuppressant (excluding steroids for lung maturity), or known case of HIV
- •Woman with high likelihood of additional surgical procedure beyond cesarean (e.g., scheduled hysterectomy, bowel, or adnexal surgery)
- •Woman already participating in another surgical study
- •Woman who received an experimental drug or used an experimental medical device within 3 months of becoming pregnant
- •Woman unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of PI
- •Employees of the PI or study center with direct involvement in the proposed study or other studies under the direction of that PI or study center
- •Any confirmed or suspected SARS-CoV-2virus/variant or COVID-19 disease
- •Other indication-based exclusion, in opinion of PI
研究者
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