Oxygen Wound Therapy Feasibility Study
Study Details
Study Description
Brief Summary
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Series Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks. |
Device: Series Topical Oxygen Therapy
Standard care provided to the whole wound followed by intervention device care to the whole wound.
|
Active Comparator: 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. |
Device: Paired Topical Oxygen Therapy
Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.
|
Outcome Measures
Primary Outcome Measures
- Change in wound area [12 weeks]
cm^2
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fisher and Paykel Healthcare
Investigators
- Principal Investigator: Jolanta Krysa, Southern DHB Vascular Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIA-297