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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
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
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
University of Alabama at Birmingham
Birmingham, Alabama, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks after baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 24 weeks after baseline
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 24 weeks after baseline