Oxygen for Vascular Incisional Healing
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Surgical Wound Healing, Lower Extremity, Revascularization, Incision
In brief
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.
Key facts
- Study ID
- NCT03746132
- Run by
- Neogenix, LLC dba Ogenix
- People needed
- 100
- Starts
- 2019-03-07
- Expected to finish
- 2022-07-31
- Last updated by the study team
- 2021-09-09
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Maryland — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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