Recruiting

Oxygen

Sponsor:

Neogenix, LLC dba Ogenix

Code:

NCT03746132

Conditions

Surgical Wound Healing

Lower Extremity

Revascularization

Incision

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EPIFLO

Study Details

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

Study ID

NCT03746132

Start date

Mar 7, 2019

Status verified date

Sep, 2021

Completion date

Jul 31, 2022

Anticipated

Primary completion date

Jul 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Transdermal Continuous Oxygen Therapy

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

no intervention: Control

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

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.

Primary outcome measure

  • surgical wound closure assessed using modified Bates-Jenson Wound Assessment Tool [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

SRINIVASAN SARANGAPANI, Ph.D.

781-702-6732ssarangapani@ogenix.com

Greg Calvitt, MBA

410-274-5883gcalvitt@ogenix.com

Locations

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Rachel C White, BSN

410-706-2143rwhite@som.umaryland.edu

More Information

Sponsor

Neogenix, LLC dba Ogenix

Last update posted

Sep 9, 2021

Last verified

Sep, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neogenix, LLC dba Ogenix on 2021-09-09.