Pressure Ulcer Healing With Microcyn

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
Oculus Innovative Sciences, Inc.
Information provided by (Responsible Party):
Yu-ying Chen, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02001558
First received: November 18, 2013
Last updated: August 6, 2014
Last verified: August 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 4 weeks after baseline [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 8 weeks after baseline [ Time Frame: 8 weeks after baseline ] [ Designated as safety issue: No ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 12 weeks after baseline [ Time Frame: 12 weeks after baseline ] [ Designated as safety issue: No ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 16 weeks after baseline [ Time Frame: 16 weeks after baseline ] [ Designated as safety issue: No ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 20 weeks after baseline [ Time Frame: 20 weeks after baseline ] [ Designated as safety issue: No ]
    measured in mm

  • pressure ulcer size (length, width and depth) at 24 weeks after baseline [ Time Frame: 24 weeks after baseline ] [ Designated as safety issue: No ]
    measured in mm


Secondary Outcome Measures:
  • Pressure Ulcer Scale for Healing (PUSH) score [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001558

Contacts
Contact: Yuying Chen, MD, PhD 205-934-3320 yychen@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Yuying Chen, MD, PhD    205-934-3320    yychen@uab.edu   
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

No publications provided

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
Study First Received: November 18, 2013
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Spinal cord injuries
Pressure ulcer

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

ClinicalTrials.gov processed this record on August 20, 2014