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Oxygen Delivery System

EO2 Oxygen Delivery for Surgical Wound Healing

Phase 2 & 3
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of a wound due to surgical intervention and closure.
Be older than 18 years old
Must not have
Excessive lymphedema
Subjects with osteomyelitis or extreme gangrene.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether using a novel oxygen diffusion dressing, the TransCu O2 Oxygen Delivery System, can improve wound healing and reduce the formation of necrotic tissue and scars.

Who is the study for?
This trial is for adults aged 18-85 with surgically closed wounds, who can consent and manage dressing changes. It's not for those with bilateral amputations, severe lymphedema, cognitive issues, active infections or conditions that a wound specialist deems risky.
What is being tested?
The study tests TransCu O2®, an oxygen diffusion dressing designed to improve healing in surgical wounds by enhancing tissue oxygenation and hydration which may prevent dead tissue and excessive scarring after surgery.
What are the potential side effects?
Potential side effects are not explicitly listed but could include skin irritation at the application site or allergic reactions to the materials used in the TransCu O2® Oxygen Delivery System.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a wound from surgery that was stitched or closed up.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe swelling due to lymph fluid.
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I have severe bone infection or extreme gangrene.
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I have Charcot Arthropathy.
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I have dementia or trouble thinking clearly.
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I have had both of my arms or legs amputated.
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I currently have an active infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in skin perfusion at baseline and 4 weeks
Change in tissue oxygenation from baseline to 4 weeks
Change in wound size from baseline to 4 weeks
+2 more
Secondary study objectives
Presence of scar tissue

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: ActiveActive Control1 Intervention
Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care.
Group II: ControlActive Control1 Intervention
Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.

Find a Location

Who is running the clinical trial?

Electrochemical Oxygen Concepts, Inc.Industry Sponsor
2 Previous Clinical Trials
166 Total Patients Enrolled
1 Trials studying Surgical Wound
20 Patients Enrolled for Surgical Wound
Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,470 Total Patients Enrolled
1 Trials studying Surgical Wound
20 Patients Enrolled for Surgical Wound

Media Library

Transcu O2® (Oxygen Delivery System) Clinical Trial Eligibility Overview. Trial Name: NCT03960463 — Phase 2 & 3
Surgical Wound Research Study Groups: Active, Control
Surgical Wound Clinical Trial 2023: Transcu O2® Highlights & Side Effects. Trial Name: NCT03960463 — Phase 2 & 3
Transcu O2® (Oxygen Delivery System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03960463 — Phase 2 & 3
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