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NCT02224638 Clinical Trial

Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Pressure Ulcers Clinical Trial

Official title:
Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02224638
Other study ID # R14-028
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2014
Est. completion date August 2015

Study information
Verified date July 2019
Source Medline Industries
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Male or female subjects of any age

- Sacral wounds with necrotic tissue

Exclusion Criteria:

- 3rd degree burns

- know hypersensitivity to products

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TheraHoney HD
Honey
• SkinTegrity
Hydrogel

Locations
Country Name City State
United States Harmony Residential Facility Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 3 weeks
Secondary Number of Participants With Adverse Events Adverse events related to the presence or absence of wound infections and worsening in ulcer staging. 3 weeks
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