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Pressure Ulcer Healing With Microcyn

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ClinicalTrials.gov Identifier: NCT02001558
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pressure Ulcer Spinal Cord Injuries Drug: Microcyn Other: Sterile saline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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
Study Start Date : March 2013
Primary Completion Date : August 2017
Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

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

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

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

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

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


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).


Eligibility Criteria

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 Posted: December 5, 2013    Key Record Dates
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:
Pressure Ulcer
Ulcer
Spinal Cord Injuries
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Skin Ulcer
Skin Diseases