Oxygen for Vascular Incisional Healing (NCT03746132) | Clinical Trial Compass
UnknownNot Applicable
Oxygen for Vascular Incisional Healing
United States100 participantsStarted 2019-03-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
surgical wound closure assessed using modified Bates-Jenson Wound Assessment Tool