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Continuous Diffusion of Oxygen Treatment for Incision Wounds

NCT04307355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-02-06

Study results available
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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

  • Surgical Wound
  • Breast Surgery
  • Mammoplasty
  • Incision Wound

Interventions

DEVICE

Transcu O2®

Breasts randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.

OTHER

Tegaderm

A 10 cm × 12 cm Tegaderm TM Film adhesive (3M Healthcare, Minnesota).

OTHER

Silagen

A 10 cm × 12 cm silicon sheet (Silagen, New Medical Technology, Inc, Illinois).

Sponsors & Collaborators

  • Electrochemical Oxygen Concepts, Inc.

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Bijan Najafi · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-08-28
Completion
2023-08-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307355 on ClinicalTrials.gov