Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

July 15, 2019 updated by: Medline Industries

Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 606025
        • Swedish Covenant Hospital
      • Chicago, Illinois, United States, 60625
        • Harmony Residential Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects of any age
  • Sacral wounds with necrotic tissue

Exclusion Criteria:

  • 3rd degree burns
  • know hypersensitivity to products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TheraHoney HD
Honey product
Device: TheraHoney HD
Honey
ACTIVE_COMPARATOR: SkinTegrity
Skin moisturizer
Device: SkinTegrity
Hydrogel
Other Names:
  • Hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 3 weeks
Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medline Industries

Investigators

  • Principal Investigator: Nancy Chaiken, RN, Swedish Covenant Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (ESTIMATE)

August 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R14-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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