Clinical Assessment of the Next Science BlastXTM Antimicrobial Gel and SurgXTM Antimicrobial Gel Healing Efficacy for Below the Knee Amputation Surgical Wound Compared to Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Percentage of Incisional Wound Area Change
研究概览
简要总结
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels as compared to standard of care.
详细描述
This is a prospective, randomized, 90 day, open-label study of patients undergoing below the knee amputation (BKA) with primary closure or completion.
Patients who present for BKA with primary closure or completion will have had 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.
A minimum of 64 participants, with up to 70 participants, may be enrolled. A participant requiring bilateral BKA will be excluded. Eligible subjects will need to complete the study to meet the primary endpoint.
It is estimated that the study enrollment period will last approximately eighteen months, and the duration of each participants' participation will be three months. Visits in the treatment portion of the study will be carried out at day 0, 3, 14, 21, and 28 days with a scheduling window of 3 days before or after each due date. A phone call follow-up will be conducted at 60 days post-surgery with a window of 7 days before or 14 days after to inquire about the incision (appearance of incision or any noted changes since prior study visit), and overall health of the participant. All participants, regardless of treatment arm, will complete Visit 6 (90 day follow up) with a scheduling window of 7 days before or 21 days after. The key parameters of the study include: percentage of surgical wound area reduction, time patients are deemed ready prosthetic healing, and microorganism type and amounts. Bacterial identification and quantification will occur at days 0, 14, and 28 for all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female 18 years or older
- •Participant must be undergoing below the knee amputation with primary closure or completion below the knee amputation with primary closure.
- •There must be no infection present at the surgical incision site
- •Participant is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
- •Must have a popliteal pressure on arterial doppler of 40 mm Hg or higher in the surgical leg or angiographic evidence of popliteal artery flow
- •No known allergic reaction or sensitivity to investigational product or components
- •Willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study
- •Provide signed and dated informed consent
排除标准
- •Male or Female less than 18 years old
- •Pregnancy as determined by pre-op urine hCG testing on the day of surgery for women of childbearing potential (women are considered clinically post-menopausal if over 12 consecutive months without a menstrual period)
- •Systemic sepsis at the time of surgery
- •Disseminated Cancer Patients
- •Current long-term (more than 30 consecutive days) use of moderate or high dose oral corticosteroids
- •Current long-term (more than 30 consecutive days) use of immune modulators/suppressors
- •Known sensitivity to investigational product or any components
- •Participants with HIV or acquired immunodeficiency syndrome (AIDS) or any other immunodeficient states
- •Any disease or prior/planned surgery or other situation that in the investigator's opinion may interfere with the participant successfully completing the study.
- •Overlapping participation in another treatment or interventional clinical trial.
- •Family members or students of the Investigator or clinical site.
- •Safety exclusion criterion: At the end of the procedure, the surgeon and PI can discuss to withdraw the patient, if it is felt that continuing in the study will be detrimental to the patient. For example, if the incision cannot be closed, or if it requires a muscle flap, or if the incision site encounters contamination or infection not recognized prior to the start of surgery. The decision to withdraw the patient will be made in the OR, prior to being randomized.
结局指标
主要结局
Percentage of Incisional Wound Area Change
时间窗: 28 Days
Incisional wounds treated with SurgX™, BlastX™ and SOC Treatment will have higher percentage of area reduction than SOC alone after 28 days of treatment.
Time to when Patient is Ready for Prosthetic Fitting
时间窗: Day 0 to 90 Days
Participants treated with SurgX™, BlastX™ and SOC treatment will be deemed ready to be fitted with a prosthetic limb earlier (days) than those in the SOC Control Group.
次要结局
- Wound Area Reduction(Baseline to 21 days)
- Bioburden(Day 0, Day 14, Day 28)