Oxygen for Vascular Incisional Healing

NCT03746132 | Unknown DMC FDA Device

• 1 other identifier: EPF-418
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vascular; Surgery; groin; incision; oxygen; infection; wound healing; Transdermal Continuos

Outcome Measures

Primary Outcomes (1)

• surgical wound closure assessed using modified Bates-Jenson Wound Assessment Tool

  Change in wound area

  4 weeks

Secondary Outcomes (1)

• Incidence of surgical site infection as determined by Szilagyi Tool

  90 days

Study Arms (2)

Transdermal Continuous Oxygen Therapy

ACTIVE COMPARATOR

Subjects who satisfy the inclusion/exclusion conditions will be randomly assigned to the Treatment arm which provides Transdermal Continuous Oxygen Treatment (TCOT) (as delivered by EPIFLO device), in addition to standard of care for the surgical wound

Device: EPIFLO

Control

NO INTERVENTION

Subjects who satisfy the inclusion/exclusion conditions will be randomly assigned to the control arm which provides standard of care for the surgical wound.

Interventions

EPIFLO DEVICE

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.

Also known as: Transdermal Continuous Oxygen Therapy

Transdermal Continuous Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Neogenix, LLC dba Ogenix: lead
• University of Maryland, College Park: collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (2)

• Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

  PMID: 41159585 DERIVED

• Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.

  PMID: 40260835 DERIVED

MeSH Terms

Conditions

Surgical Wound; Infections

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Khanjan Nagarsheth, MD

  University of Maryland, School of Medicine, Baltimore MD

  PRINCIPAL INVESTIGATOR

• Brajesh K Lal

  University of Maryland, School of Medicine, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SRINIVASAN SARANGAPANI, Ph.D.

CONTACT

781-702-6732; ssarangapani@ogenix.com

Greg Calvitt, MBA

CONTACT

410-274-5883; gcalvitt@ogenix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: March 7, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)