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Continuous Diffusion of Oxygen Treatment for Incision Wounds
NCT04307355 · View on ClinicalTrials.gov ↗
Study Summary
This is an exploratory randomized controlled trial study to test feasibility, acceptability, and proof of concept efficacy of Continuous Diffusion of Oxygen (CDO) adjunct therapy for decreasing healing time and reducing tissue necrosis post breast reconstruction. The investigator will assess the benefit of this novel adjunct therapy on successful closure, tissue oxygenation, scar appearance, and patients centered outcomes including perception of benefit, pain, sleep quality, and quality of life. Eligible subjects will be randomly (ratio 1:1) assigned to either intervention group (IG) or control group (CG) and will be followed for four weeks. Both groups will receive standard of care for wound treatment. IG will also receive CDO adjunct therapy using a novel dressing, which facilitates continuously supplies oxygen to the wound inside the wound dressing using a portable device named TransCu O2. The study device TransCu O2® is a Class II medical device which has US Food and Drug Administration (FDA) 510(k) clearance, CE-Mark approval and a Health Canada license for the treatment of wounds. Outcomes will be assessed on weekly-basis up to 4 weeks.
Conditions Studied
Interventions
- DEVICE Transcu O2®
- OTHER Tegaderm
- OTHER Silagen
Study Locations (1)
Texas
- Baylor College of Medicine — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2023-08-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04307355
The ClinicalTrials.gov registry entry for NCT04307355 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Surgical Wound appearing as the primary indexed condition, and to 3 interventions — of which Transcu O2® is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04307355 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04307355 about?
NCT04307355 is a clinical study titled "Continuous Diffusion of Oxygen Treatment for Incision Wounds". This is an exploratory randomized controlled trial study to test feasibility, acceptability, and proof of concept efficacy of Continuous Diffusion of Oxygen (CDO) adjunct therapy for decreasing healing time and reducing tissue necrosis post breast reconstruction. The investigator will assess the ben...
What is the current status of trial NCT04307355?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2021-06-01. Estimated completion is 2023-08-28.
What conditions does trial NCT04307355 study?
This clinical trial studies the following conditions: Surgical Wound, Breast Surgery, Mammoplasty, Incision Wound. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04307355?
The interventions under investigation include: Transcu O2® (DEVICE), Tegaderm (OTHER), Silagen (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04307355?
This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04307355 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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