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Oxygen for Vascular Incisional Healing

NCT03746132 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-09-09

No results posted yet for this study

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.

Conditions

  • Surgical Wound Healing
  • Lower Extremity
  • Revascularization
  • Incision

Interventions

DEVICE

EPIFLO

EPIFLO is a 3 ounce oxygen generator that continuously delivers 3 ml/hr of pure oxygen to the wound site, to enable tissue regenerative processes, thus driving closure of delayed-healing acute or chronic wounds.

Sponsors & Collaborators

  • University of Maryland, College Park

    collaborator OTHER

  • Neogenix, LLC dba Ogenix

    lead INDUSTRY

Principal Investigators

  • Khanjan Nagarsheth, MD · University of Maryland, School of Medicine, Baltimore MD

  • Brajesh K Lal · University of Maryland, School of Medicine, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03746132 on ClinicalTrials.gov