Pressure Ulcer Healing With Microcyn

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pressure Ulcer, Spinal Cord Injuries

Intervention / Treatment
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* Drug: Microcyn
* Other: Sterile saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microcyn<br>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. | Drug: Microcyn<br>* 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<br>* Other names: Microcyn® Skin and Wound Care with preservatives;|
| Active Comparator: Sterile saline<br>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. | Other: Sterile saline<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. | pressure ulcer size (length x width x depth, cm^3) at baseline | 
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 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. | 4 weeks after baseline | 
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 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. | 8 weeks after baseline | 
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 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. | 12 weeks after baseline | 
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 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. | 16 weeks after baseline | 
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 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. | 20 weeks after baseline | 
| Pressure Ulcer Size (Length x Width x Depth, cm^3) at 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. | 24 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Ulcer Scale for Healing (PUSH) Score | 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). | at baseline | 
| Pressure Ulcer Scale for Healing (PUSH) Score at 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). | 4 weeks after baseline | 
| Pressure Ulcer Scale for Healing (PUSH) Score at 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). | 8 weeks after baseline | 
| Pressure Ulcer Scale for Healing (PUSH) Score at 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). | 12 weeks after baseline | 
| Pressure Ulcer Scale for Healing (PUSH) Score at 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). | 16 weeks after baseline | 
| Pressure Ulcer Scale for Healing (PUSH) Score at 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). | 20 weeks after baseline | 
| Pressure Ulcer Scale for Healing (PUSH) Score at 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). | 24 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injuries, Pressure ulcer