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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a wound from surgery that was stitched or closed up.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Presence of scar tissue
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.
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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
1,001 Previous Clinical Trials
6,002,212 Total Patients Enrolled
1 Trials studying Surgical Wound
20 Patients Enrolled for Surgical Wound
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe swelling due to lymph fluid.I have severe bone infection or extreme gangrene.I have Charcot Arthropathy.I have a wound from surgery that was stitched or closed up.I am between 18 and 85 years old and can give my consent.You are currently using drugs or alcohol regularly, or have used them in the past month.I have dementia or trouble thinking clearly.I have had both of my arms or legs amputated.I currently have an active infection.I or my caregiver can manage the necessary wound care and dressing changes.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could elderly patients participate in this trial?
"This trial is for patients aged 18-85, which falls in the middle of the 218 trials for patients under 18 and the 2482 trials for patients over 65."
Answered by AI
What is the anticipated patient recruitment for this clinical trial?
"That is correct. The clinical trial is still looking for 40 individuals to enroll at a single location. According to the website, the first posting was on May 18th, 2017 and the most recent edit was on January 19th, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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