Clinical Assessment of How Next Science XPERIENCE No Rinse Antimicrobial Solution May Promote Wound Healing by Decreasing Post-Operative Infections in Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Surgical Site Infection
研究概览
简要总结
This is a prospective, randomized, controlled, double-blinded clinical feasibility study of subjects that are being treated for Gustilo and Anderson Type II or IIIA or IIIB Tibial Fractures
详细描述
This is a prospective, controlled, double-arm, double-blinded, randomized clinical study of 30 subjects that are undergoing single stage surgical repair of Type II or IIIA or IIIB tibial fractures.
Institutional Review Board (IRB) approval is required before the site can begin enrolling patients. Additionally, protocol amendments need to be approved by the IRB prior to starting any changes or procedures stemming from the amended protocol. Potentially eligible patients will be offered study enrollment and all subjects are required to participate in the informed consent process and sign the most recent IRB-approved written informed consent document prior to being enrolled in the study. If all the study inclusion/exclusion criteria are met, patients will be presented with the option to participate in the study and informed consent procedures will be carried out, in compliance with currently applicable subjects' rights and safety regulations. Reconsenting procedures for cases of protocol amendments will be performed in compliance with the IRB.
Patients who present for open tibial fracture repair surgery will have a pre-op medical evaluation prior to being screened against the protocol's inclusion/exclusion criteria. If criteria are met, patients will be presented with the option to participate in the study, and informed consent procedures will be carried out, in compliance with currently applicable participants' rights and safety regulations. At the time of surgery, participants determined to require surgical repair of a Type IIIC tibial fracture will be excluded. Patients who continue to be eligible meeting inclusion/exclusion criteria at the time of surgery will be randomized to one of the two treatment arms: SOC with Saline or SOC plus Next Science treatment. The treatment assignment will be predetermined by a randomization plan within Castor Electronic Data Capture (EDC) system. Although, paper source documents will be used to obtain subject data, randomization will be primarily through the EDC system. As a back-up, should the EDC system be unavailable at that time, randomization will occur using a sealed envelope system.
The following must have occurred prior to determining treatment assignment:
- Screening
- Participant must meet all eligibility requirements
- Informed Consent must be signed
- Continued Eligibility screening
- Randomization must occur*
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Due to the double-blinded nature of the study, neither the participant, treating physician, site staff, or site study team will be aware of the treatment assignment (XPERIENCE No-Rinse Antimicrobial Solution or blinded saline) of each subject.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 65 years old
- •Scheduled to undergo surgery to repair open tibial fracture
- •Willing and able to comply with all study procedures and be available for the duration of the study
- •Provide signed and dated informed consent or obtain consent from legally authorized representative
- •Not be pregnant, planning to become pregnant, or nursing female subjects.
排除标准
- •Unable to provide signed and dated informed consent or unable to obtain consent from a legally authorized representative
- •Unable or unwilling to comply with all study-related procedures
- •Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)
- •Subject has known history of contraindications to general anesthesia
- •Subject with any underlying condition or state that, in the investigator's opinion, will make them too critically ill to complete 30 and/or 90 day follow ups
- •Pregnant, planning to become pregnant, or nursing female subjects.
- •Any subject positive for Covid-19 virus at time of surgical screening
- •Tibial plateau, pilon, or Gustilo-Anderson type IIIc fractures and any fracture that will require referral to another surgical service will be excluded from this study
- •Any patient who will require ongoing use of NPWT after hospital discharge will be excluded from the study.
- •Subjects have evidence of prolonged QT segment, per EKG.
- •Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
研究组 & 干预措施
Standard of Care
Each of the following procedures will be conducted according to general or local site Standard of Care (SoC):
- Medication administration at surgery
- Surgical irrigation and wound debridement
- Surgical fracture preparation/fixation
- Surgical closure
干预措施: Standard of Care (Other)
Standard of Care plus Next Science
In addition to the SoC, the blinded product will be applied in place of saline irrigation as the wound is closed (after bone fracture preparation/fixation), depending on the randomization.
干预措施: Next Science (Device)
结局指标
主要结局
Surgical Site Infection
时间窗: 90 days
Proportion of subjects that develop a surgical site infection (superficial, deep, or organ space) from surgery to post-op Day 90 for the Next Science Group compared to the Control group.
次要结局
- Deep Bioburden(1 day)
- Superficial Bioburden(90 days)