Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2022-12-01
2026-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Series
Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks.
Series Topical Oxygen Therapy
Standard care provided to the whole wound followed by intervention device care to the whole wound.
Paired
Intervention device wound care to a portion of wound and standard wound care to the remaining portion of the wound, for up to 12 weeks.
Paired Topical Oxygen Therapy
Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.
Interventions
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Series Topical Oxygen Therapy
Standard care provided to the whole wound followed by intervention device care to the whole wound.
Paired Topical Oxygen Therapy
Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.
Eligibility Criteria
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Inclusion Criteria
* Patient has a wound area greater than the area of the interface
* Aged 16 years and over
* Able to provide informed consent
Exclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Jolanta Krysa
Role: PRINCIPAL_INVESTIGATOR
Southern DHB Vascular Surgery
Locations
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Otago Vascular Diagnostics
Dunedin, Otago, New Zealand
Countries
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Central Contacts
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Facility Contacts
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Clinical Director
Role: primary
Clinical Nurse Specialist
Role: backup
Other Identifiers
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CIA-297
Identifier Type: -
Identifier Source: org_study_id
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