Surgical Wound Clinical Trial
Official title:
Evaluation of Oxygen Delivery With TransCu O2 to Study Success Rate of Surgically Closed 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 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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Electrochemical Oxygen Concepts, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of complication from baseline to 4 weeks | Complication is described as infection, dehiscence, necrotic tissue | baseline to 4 weeks | |
Primary | Change in wound size from baseline to 4 weeks | wound size will be quantified using wound imaging systems | baseline to 4 weeks | |
Secondary | Presence of scar tissue | Scar presence will be assessed with imaging systems. | Time Frame: baseline to 4 weeks | |
Secondary | Change in skin perfusion at baseline and 4 weeks | skin perfusion will be assessed Skin Perfusion Pressure Test (SPP) | baseline to 4 weeks | |
Secondary | Self-reported pain change at every week | Pain will be assessed with visual analogue scale from 0 to 10 where 10 is the worst pain ever. | Baseline to 4 weeks | |
Secondary | Change in tissue oxygenation from baseline to 4 weeks | Tissue Oxygenation will be assessed by a non-invasive tissue oxygenation measurement system (Snapshot, Kent Imaging) | baseline to 4 weeks |
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