Back to resultsWound Management for Sacral Pressure Ulcers With Necrotic Tissue
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TheraHoney HD
SkinTegrity
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers focused on measuring skin ulcers
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects of any age
- Sacral wounds with necrotic tissue
Exclusion Criteria:
- 3rd degree burns
- know hypersensitivity to products
Sites / Locations
- Swedish Covenant Hospital
- Harmony Residential Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TheraHoney HD
SkinTegrity
Arm Description
Honey product
Skin moisturizer
Outcomes
Primary Outcome Measures
Percentage of Wounds Healed
Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer
Secondary Outcome Measures
Number of Participants With Adverse Events
Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02224638
Brief Title
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Official Title
Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medline Industries
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
skin ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TheraHoney HD
Arm Type
Active Comparator
Arm Description
Honey product
Arm Title
SkinTegrity
Arm Type
Active Comparator
Arm Description
Skin moisturizer
Intervention Type
Device
Intervention Name(s)
TheraHoney HD
Intervention Description
Honey
Intervention Type
Device
Intervention Name(s)
SkinTegrity
Other Intervention Name(s)
Hydrogel
Intervention Description
Hydrogel
Primary Outcome Measure Information:
Title
Percentage of Wounds Healed
Description
Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.
Time Frame
3 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects of any age
Sacral wounds with necrotic tissue
Exclusion Criteria:
3rd degree burns
know hypersensitivity to products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Chaiken, RN
Organizational Affiliation
Swedish Covenant Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606025
Country
United States
Facility Name
Harmony Residential Facility
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
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