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Continuous Diffusion of Oxygen Treatment for Incision Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04307355
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : October 12, 2021
Sponsor:
Collaborator:
Electrochemical Oxygen Concepts, Inc.
Information provided by (Responsible Party):
Bijan Najafi, PhD, Baylor College of Medicine

Brief 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.


Condition or disease Intervention/treatment Phase
Surgical Wound Breast Surgery Mammoplasty Incision Wound Device: Transcu O2® Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Oxygen Delivery With TransCu O2 to Study Success Rate of Surgically Closed Wounds
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 6, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active
Participants will be provided with a Transcu O2 ® Oxygen delivery system at the surgical site for 4 weeks as supportive care.
Device: Transcu O2®
Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.

No Intervention: Control
Participants will be placed in a standard dressing at the surgical site and will be followed for 4 weeks.



Primary Outcome Measures :
  1. Incidence of complication from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    Complication is described as infection, dehiscence, necrotic tissue

  2. Change in wound size from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    wound size will be quantified using wound imaging systems


Secondary Outcome Measures :
  1. Presence of scar tissue [ Time Frame: Time Frame: baseline to 4 weeks ]
    Scar presence will be assessed with imaging systems.

  2. Change in skin perfusion at baseline and 4 weeks [ Time Frame: baseline to 4 weeks ]
    skin perfusion will be assessed Skin Perfusion Pressure Test (SPP)

  3. Self-reported pain change at every week [ Time Frame: Baseline to 4 weeks ]
    Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever.

  4. Change in tissue oxygenation from baseline to 4 weeks [ Time Frame: baseline to 4 weeks ]
    Tissue Oxygenation will be assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-85 years of age
  • Ability to provide informed consent
  • Presence of a wound due to surgical intervention and closure
  • 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

Exclusion Criteria:

  • Active Drug/alcohol abuse (or history of drug/alcohol abuse in last 1 month)
  • Dementia or severely impaired cognitive function
  • excessive lymphedema
  • presence of active infection
  • subject has a history of or any intercurrent illnesses or conditions that would compromise the safety of the subject according to judgement of a qualified wound specialist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307355


Contacts
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Contact: Bijan Najafi, PhD 713-798-7536 bijan.najafi@bcm.edu
Contact: Maria Noun 713-798-7538 maria.noun@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Maria Noun    713-798-7538    maria.noun@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Electrochemical Oxygen Concepts, Inc.
Investigators
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Principal Investigator: Bijan Najafi Baylor College of Medicine
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Responsible Party: Bijan Najafi, PhD, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04307355    
Other Study ID Numbers: H-46332
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
Infection
Dehiscense
Tissue infection
Surgical Revision
Scar tissue
Wound Closure
Additional relevant MeSH terms:
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Wounds and Injuries
Surgical Wound