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Oxygen for Vascular Incisional Healing
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.
Details
| Lead sponsor | Neogenix, LLC dba Ogenix |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 100 |
| Start date | Thu Mar 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun Jul 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Surgical Wound Healing
- Lower Extremity
- Revascularization
- Incision
Interventions
- EPIFLO
Countries
United States