MedTrace Logo

EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

NCT03960463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-01-23

Study results available
· View outcomes & findings →

Summary

The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds.

The investigators hypothesize that using this novel oxygen diffusion dressing will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.

Conditions

  • Surgical Wound
  • Diabetes
  • Amputation Wound
  • Incision Wound
  • Peripheral Arterial Disease
  • Breast Cancer
  • Diabetic Foot

Interventions

DEVICE

Transcu O2®

Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.

Sponsors & Collaborators

  • Electrochemical Oxygen Concepts, Inc.

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-18
Primary Completion
2023-12-15
Completion
2024-07-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03960463 on ClinicalTrials.gov