Pressure Ulcer Healing With Microcyn

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Spinal Cord Injuries; Pressure Ulcer

Treatments: Drug: Microcyn; Other: Sterile saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02001558

MIC-UABWC-001

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Microcyn

Experimental group

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.

Treatment:

Drug: Microcyn

Sterile saline

Active Comparator group

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.

Treatment:

Other: Sterile saline