NCT02224638CompletedPhase 4
Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Medline Industries2 sites in 1 country21 target enrollmentStarted: December 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Percentage of Wounds Healed
Study Overview
Brief Summary
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds
Detailed Description
Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects of any age
- •Sacral wounds with necrotic tissue
Exclusion Criteria
- •3rd degree burns
- •know hypersensitivity to products
Arms & Interventions
TheraHoney HD
Active Comparator
Honey product
Intervention: TheraHoney HD (Device)
SkinTegrity
Active Comparator
Skin moisturizer
Intervention: SkinTegrity (Device)
Outcomes
Primary Outcomes
Percentage of Wounds Healed
Time Frame: 3 weeks
Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer
Secondary Outcomes
- Number of Participants With Adverse Events(3 weeks)
Investigators
Study Sites (2)
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