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Oxygen Therapy for Surgical Wounds After Breast Surgery

Phase 1 & 2
Recruiting
Led By Bijan Najafi
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
18-85 years of age
Subject or responsible caregiver is willing and able to maintain the required Continuous Diffusion of Oxygen (CDO) system (if assigned to the intervention group) and applicable dressing changes
Must not have
Dementia or severely impaired cognitive function
excessive lymphedema
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new oxygen therapy can help heal wounds and reduce scarring after breast reconstruction surgery. The study will last 4 weeks and participants will be followed weekly.

Who is the study for?
This trial is for individuals aged 18-85 who have a wound from breast reconstruction surgery and can consent to treatment. They must be able to manage the oxygen system if needed. People with dementia, severe lymphedema, active infections, or recent drug/alcohol abuse cannot participate.
What is being tested?
The study tests Continuous Diffusion of Oxygen (CDO) therapy using TransCu O2®, a device that supplies oxygen directly to wounds, against standard care alone. Participants are randomly assigned to either receive CDO plus standard care or just standard care for four weeks.
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include skin irritation from the dressing or device, discomfort related to continuous oxygen supply, and possible complications from increased oxygen exposure at the wound site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I or my caregiver can manage the oxygen system and dressing changes if needed.
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I have a wound from recent surgery that was closed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have dementia or severe cognitive issues.
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I have severe swelling due to lymph fluid buildup.
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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 wound size from baseline to 4 weeks
Incidence of complication from baseline to 4 weeks
Secondary study objectives
Change in skin perfusion at baseline and 4 weeks
Change in tissue oxygenation from baseline to 4 weeks
Presence of scar tissue
+1 more

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?

Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,142 Total Patients Enrolled
1 Trials studying Surgical Wound
40 Patients Enrolled for Surgical Wound
Electrochemical Oxygen Concepts, Inc.Industry Sponsor
2 Previous Clinical Trials
186 Total Patients Enrolled
1 Trials studying Surgical Wound
40 Patients Enrolled for Surgical Wound
Bijan NajafiPrincipal InvestigatorBaylor College of Medicine

Media Library

Active Clinical Trial Eligibility Overview. Trial Name: NCT04307355 — Phase 1 & 2
Surgical Wound Research Study Groups: Active, Control
Surgical Wound Clinical Trial 2023: Active Highlights & Side Effects. Trial Name: NCT04307355 — Phase 1 & 2
Active 2023 Treatment Timeline for Medical Study. Trial Name: NCT04307355 — Phase 1 & 2
~4 spots leftby Dec 2025
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