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Pressure Ulcer Healing With Microcyn

Primary Purpose

Pressure Ulcer, Spinal Cord Injuries

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Microcyn
Sterile saline
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer focused on measuring Spinal cord injuries, Pressure ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Microcyn

Sterile saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
November 18, 2013
Last Updated
October 8, 2018
Sponsor
University of Alabama at Birmingham
Collaborators
Oculus Innovative Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02001558
Brief Title
Pressure Ulcer Healing With Microcyn
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Oculus Innovative Sciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Spinal Cord Injuries
Keywords
Spinal cord injuries, Pressure ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microcyn
Arm Type
Experimental
Arm Description
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.
Arm Title
Sterile saline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Microcyn
Other Intervention Name(s)
Microcyn® Skin and Wound Care with preservatives
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sterile saline
Intervention Description
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 Outcome Measure Information:
Title
Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline
Description
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
Title
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline
Description
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
Title
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline
Description
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
Title
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline
Description
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
Title
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline
Description
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
Title
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline
Description
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
Title
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline
Description
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
Secondary Outcome Measure Information:
Title
Pressure Ulcer Scale for Healing (PUSH) Score
Description
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
Title
Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline
Description
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
Title
Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline
Description
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
Title
Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline
Description
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
Title
Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline
Description
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
Title
Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline
Description
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
Title
Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuying Chen, MD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

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Pressure Ulcer Healing With Microcyn

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