Pressure Ulcer Healing With Microcyn

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

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 Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Pressure Ulcer
• Intervention / Treatment: Drug: Microcyn; Other: Sterile saline

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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 Names: Microcyn® Skin and Wound Care with preservatives
ACTIVE_COMPARATOR: 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.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Oculus Innovative Sciences, Inc.
• Investigators: Principal Investigator: Yuying Chen, MD, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (ESTIMATE): December 5, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Pressure ulcer; Spinal cord injuries
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Wounds and Injuries; Skin Ulcer; Trauma, Nervous System; Spinal Cord Diseases; Ulcer; Spinal Cord Injuries; Pressure Ulcer
• Other Study ID Numbers: MIC-UABWC-001