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Pressure Ulcer Healing With Microcyn

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02001558
First Posted: December 5, 2013
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oculus Innovative Sciences, Inc.
Information provided by (Responsible Party):
Yu-ying Chen, University of Alabama at Birmingham
  Purpose
The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure ulcers compared to sterile saline among persons with spinal cord injury.

Condition Intervention Phase
Pressure Ulcer Spinal Cord Injuries Drug: Microcyn Other: Sterile saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Six Month Randomized Open-Label Trial of Pressure Ulcer Healing With Microcyn® Skin and Wound Care With Preservatives Versus Sterile Saline in Adult Spinal Cord Injury Subjects

Resource links provided by NLM:


Further study details as provided by Yu-ying Chen, University of Alabama at Birmingham:

Primary Outcome Measures:
  • pressure ulcer size (length, width, depth) [ Time Frame: pressure ulcer size (length, width and depth) at baseline ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 4 weeks after baseline [ Time Frame: 4 weeks after baseline ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 8 weeks after baseline [ Time Frame: 8 weeks after baseline ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 12 weeks after baseline [ Time Frame: 12 weeks after baseline ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 16 weeks after baseline [ Time Frame: 16 weeks after baseline ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 20 weeks after baseline [ Time Frame: 20 weeks after baseline ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 24 weeks after baseline [ Time Frame: 24 weeks after baseline ]
    measured in mm


Secondary Outcome Measures:
  • Pressure Ulcer Scale for Healing (PUSH) score [ Time Frame: at baseline ]
    PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).

  • Pressure Ulcer scale for Healing (PUSH) score at 4 weeks after baseline [ Time Frame: 4 weeks after baseline ]
    PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).

  • Pressure Ulcer scale for Healing (PUSH) score at 8 weeks after baseline [ Time Frame: 8 weeks after baseline ]
    PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).

  • Pressure Ulcer scale for Healing (PUSH) score at 12 weeks after baseline [ Time Frame: 12 weeks after baseline ]
    PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).

  • Pressure Ulcer scale for Healing (PUSH) score at 16 weeks after baseline [ Time Frame: 16 weeks after baseline ]
    PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).

  • Pressure Ulcer scale for Healing (PUSH) score at 20 weeks after baseline [ Time Frame: 20 weeks after baseline ]
    PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).

  • Pressure Ulcer scale for Healing (PUSH) score at 24 weeks after baseline [ Time Frame: 24 weeks after baseline ]
    PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).


Enrollment: 65
Study Start Date: March 2013
Study Completion Date: August 2017
Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microcyn Drug: Microcyn
Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24
Other Name: Microcyn® Skin and Wound Care with preservatives
Active Comparator: Sterile saline Other: Sterile saline
Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 17 years
  • Persons with spinal cord injury
  • Having Stage III/IV pressure ulcer(s)
  • Able to fulfill all obligations of the study

Exclusion Criteria:

  • Pressure ulcers scheduled for surgical closure within 14 days
  • Use of any immunosuppressant medications within 30 days of screening
  • Having conditions that put the subject at significant risk
  • Medically unstable or has a life expectancy of less than 12 months
  • Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days
  • Pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001558


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Oculus Innovative Sciences, Inc.
Investigators
Principal Investigator: Yuying Chen, MD, PhD University of Alabama at Birmingham
  More Information

Responsible Party: Yu-ying Chen, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02001558     History of Changes
Other Study ID Numbers: MIC-UABWC-001
First Submitted: November 18, 2013
First Posted: December 5, 2013
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by Yu-ying Chen, University of Alabama at Birmingham:
Spinal cord injuries
Pressure ulcer

Additional relevant MeSH terms:
Ulcer
Spinal Cord Injuries
Pressure Ulcer
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Skin Ulcer
Skin Diseases