Status:
COMPLETED
Continuous Diffusion of Oxygen Treatment for Incision Wounds
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Electrochemical Oxygen Concepts, Inc.
Conditions:
Surgical Wound
Breast Surgery
Eligibility:
All Genders
18-85 years
Phase:
NA
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 healin...
Detailed Description
Surgical wound complications such as infection, dehiscence, necrotic tissue, surgical revision, and poor cosmesis are unfortunately highly prevalent in patients post breast reconstruction. In particul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04307355
Start Date
June 1 2021
End Date
August 28 2023
Last Update
February 6 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030