Pressure Ulcer Healing With Microcyn

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001558
• Other study ID #: MIC-UABWC-001
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: August 2017

Study information

• Verified date: October 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Spinal Cord Injuries
• Ulcer

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Oculus Innovative Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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