RecruitingNot ApplicableNCT05422248
Oxygen Wound Therapy Feasibility Study
Sponsor
Fisher and Paykel Healthcare
Enrollment
10 participants
Start Date
Dec 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
Eligibility
Min Age: 16 Years
Inclusion Criteria4
- Patients with hard to heal lower leg wounds as determined by the treating clinician.
- Patient has a wound area greater than the area of the interface
- Aged 16 years and over
- Able to provide informed consent
Exclusion Criteria5
- Lower limb wounds with bone or tendon exposed
- Infected wounds which require treatment with antibiotics
- Wounds with critical bioburden requiring a medicated dressing
- Wounds that require dressing changes more than every second day, for example high exudating wounds
- Wounds with slough covering more than 30% of the wound surface
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Interventions
DEVICESeries Topical Oxygen Therapy
Standard care provided to the whole wound followed by intervention device care to the whole wound.
DEVICEPaired Topical Oxygen Therapy
Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05422248