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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in wound size from baseline to 4 weeks
Incidence of complication from baseline to 4 weeks
Secondary outcome measures
Change in skin perfusion at baseline and 4 weeks
Change in tissue oxygenation from baseline to 4 weeks
Presence of scar tissue
+1 more

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
1,002 Previous Clinical Trials
6,002,784 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of all ages being considered for involvement in this research?

"The eligibility requirements for this study mandate that participants must fall between 18 to 85 years of age. Clinicialtrials.gov lists 126 trials specifically targeting patients under the legal age of consent and 661 studies recruiting those over 65."

Answered by AI

Am I eligible to partake in this clinical experiment?

"This clinical trial is looking for 20 volunteers aged between 18 and 85 with a surgical wound. Additional criteria include the capacity to implement Continuous Diffusion of Oxygen (CDO) procedure in the intervention group, as well as suitable dressing changes if necessary."

Answered by AI

What is the uppermost participant limit for this research endeavor?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, which was first released on 6th June 2021, is actively recruiting for its cohort of 20 patients from one site."

Answered by AI

Does this trial currently have open enrollment?

"Correct. Clinicaltrials.gov records that this research endeavour, which was first announced on June 1st 2021, is still recruiting volunteers. 20 participants must be sourced from one medical site for the trial to continue as planned."

Answered by AI

What objectives is this investigation attempting to realize?

"As reported by the trial sponsor, Electrochemical Oxygen Concepts, Inc., the primary goal of this experiment is to assess Change in wound size from baseline to 4 weeks. Alongside this metric, Self-reported pain change at every week will be measured through visual analogue scale and Skin Perfusion Pressure Test (SPP) as well as Tissue Oxygenation via a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Continuous Diffusion of Oxygen Treatment for Incision Wounds
Bijan Najafi, PhD 2021. "Continuous Diffusion of Oxygen Treatment for Incision Wounds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04307355.
~3 spots leftby Dec 2024
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