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Completed

NCT Number: NCT02001558

Pressure Ulcer Healing With Microcyn

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.

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Key information

Conditions

Pressure Ulcer Central Nervous System Diseases Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microcyn

Drug

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 names: Microcyn® Skin and Wound Care with preservatives

sterile saline

Other

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

Primary outcomes

  1. Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline

    Time frame: pressure ulcer size (length x width x depth, cm^3) at baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

  2. Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline

    Time frame: 4 weeks after baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

  3. Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline

    Time frame: 8 weeks after baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

  4. Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline

    Time frame: 12 weeks after baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

  5. Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline

    Time frame: 16 weeks after baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

  6. Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline

    Time frame: 20 weeks after baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

  7. Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline

    Time frame: 24 weeks after baseline

    Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Oculus Innovative Sciences, Inc.

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2013
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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