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NCT04307355 · ClinicalTrials.gov registry record · NA
Continuous Diffusion of Oxygen Treatment for Incision Wounds
A NA study of Surgical Wound and Breast Surgery, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT04307355 is a NA study of Surgical Wound and Breast Surgery that has completed, run by Baylor College of Medicine. The registered enrollment target is 23 participants, below the 94-participant average among 17 other Surgical Wound trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04307355, a NA study of Surgical Wound and Breast Surgery, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
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, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 94-participant average among 17 other Surgical Wound trials with a reported enrollment target (76% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
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.
NCT04307355 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
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.
What interventions are being tested in trial NCT04307355?
The interventions under investigation include: Transcu O2® (DEVICE), Tegaderm (OTHER), Silagen (OTHER).
Who is sponsoring clinical trial NCT04307355?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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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Related
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