sing a biodegradable polyurethane foam in comparison with Granufoam (black, non-biodegradable foam) with Vacuum-Assisted Closure in the management of decubitus ulcers (pressure sores)
Not Applicable
Completed
- Conditions
- Pressure sores (decubitus ulceration)Skin - Other skin conditions
- Registration Number
- ACTRN12611000815965
- Lead Sponsor
- ovoWound Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Ischial or sacral pressure sore; >18 years old; suitable for topical negative pressure after wound debridement; able to provide informed consent
Exclusion Criteria
Pregnancy; inability to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability to transmit topical negative pressure to the wound bed (assessed by odour, reduction of oedema, development of vascular granulations, cleanliness, wound area) with assessment by an independent specialist woundcare nurse, photographic analysis and wound area measurement.[Every 2-3 days for 8 weeks.]
- Secondary Outcome Measures
Name Time Method Safety (assessed by absence of local or systemic effects attributable to the new material). This can only be assessed by direct comparison with the control material, both within the study and against historical experience.[Every 2-3 days for 8 weeks.]