A Prospective, Randomized, Crossover Study of Transdermal, Continuous Oxygen Therapy for Surgical Site Wound Healing in High- Risk Subjects Undergoing Lower Extremity Revascularization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- surgical wound closure assessed using modified Bates-Jenson Wound Assessment Tool
研究概览
简要总结
The purpose of this clinical trial is to evaluate Transdermal Continuous Oxygen Therapy (TCOT) as an adjunct to surgical wound healing in subjects undergoing vascular surgery for lower extremity arterial occlusive disease. It is the intention of this study to administer oxygen using the TCOT approach to the surgical sites of subjects undergoing the surgery and to monitor the healing of the incision as well as infection rate. The hypothesis is that oxygen delivered transdermally to the surgical site in a continuous manner for up to 28 days will accelerate the healing process and reduce the infection rate compared to the Standard of Care.
详细描述
This Safety & Efficacy Study will be a randomized controlled trial of 100 subjects (Parallel design) aged 18 - 90 years who are scheduled to undergo vascular surgery at the University of Maryland Medical Center (UMMC) hospital. 50 subjects will be recruited for the control arm and 50 for the treatment arm. Subjects who meet the inclusion/exclusion criteria will be randomized to receive the treatment device with Standard of Care or Standard of Care alone (1:1). The most proximal (e.g., groin) incision (subject to safety exclusion) will be studied.
The expected study treatment duration is 4 weeks. This means the subjects will be seeing their physician weekly for the first 4 weeks following their surgery, once they are recruited for the study.
During the study, there will be five study treatment visits: Study visit 1 (day 0) is the day of the surgery and of randomization. For those randomized to the treatment arm of the study, the EPIFLO device will be applied on this day immediately following surgery. For those randomized to the control group, standard gauze dressing will be applied to their incision site. The second study visit is 7 days following surgery (day 7) and the third, fourth, and fifth study visits are on days 14, 21, and 28 respectively. On the third study visit (day 14), a new EPIFLO will be applied and the old one discarded for those in the treatment arm of the study, because FDA has cleared each EPIFLO-15 device only for a maximum of 15 days of use, after which the used device must be disposed (single use, single patient, disposable device). The 5th study visit (Day 28), will be the final treatment study visit for all subjects, regardless of which treatment group they are in.
Those subjects whose incisional wound has healed during the study treatment period (28 days) will come in for a healing confirmation visit two weeks after it's noted to be healed. Note that an incision is not declared healed until the healing is confirmed after a two-week period after the first observation of complete healing. They will then have one final study visit, approximately 90 days from the first observation of wound closure, as their last study visit.
All subjects whose incisions have not completely healed by the fifth study visit (day 28) will also come in for one final study visit, approximately 90 days following their surgery, to have the study doctor assess the condition of the incision.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Sham devices are not involved in this study. The surgeon will remain blinded to the subject's group assignment until after the wound is surgically closed in the operating room, and just prior to application of the dressing. A clinical professional, experienced in care of surgical wounds, will be appointed at the end of the study as a masked independent evaluator. This clinical professional will be blinded as to the treatment group of the subject.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective Surgery
- •Clean incisions
- •Surgery being performed for lower extremity arterial occlusive disease
- •Subject Age 18- 90
- •Willing and capable of signing informed consent and following all study protocols
排除标准
- •Pregnancy
- •Surgical site has abscess or cellulitis
- •Systemic sepsis at the time of surgery
- •Disseminated Cancer Patients
- •Arterial entrapment
- •Chronic moderate or high dose oral corticosteroid use
- •Subjects on chronic immune modulators/suppressors
- •Known sensitivity to investigational device
- •Subjects with acquired immunodeficiency syndrome (AIDS)
- •Any disease or prior/planned surgery that in the investigator's opinion may interfere with the subject 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 randomization. The decision to withdraw the patient will be made in the OR, prior to being randomized.
结局指标
主要结局
surgical wound closure assessed using modified Bates-Jenson Wound Assessment Tool
时间窗: 4 weeks
Change in wound area
次要结局
- Incidence of surgical site infection as determined by Szilagyi Tool(90 days)