Pressure Ulcer Healing With Microcyn

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-08-31

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.

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Detailed Description

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Conditions

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Pressure Ulcer Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Microcyn

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Sterile saline

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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Microcyn® Skin and Wound Care with preservatives

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No