Pressure Ulcer Healing With Microcyn

Phase 4

Completed

• Conditions: Pressure Ulcer; Spinal Cord Injuries
• Interventions: Drug: Microcyn; Other: Sterile saline

• Registration Number: NCT02001558
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-05
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2018-08-28
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-08
• Last Update Submitted: 2018-10-08
• Results First Posted: 2018-11-06
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microcyn	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.
Sterile saline	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.

Primary Outcome Measures

Name	Time	Method
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline	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 4 Weeks After Baseline	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 12 Weeks After Baseline	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 8 Weeks After Baseline	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 Baseline	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 16 Weeks After Baseline	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 24 Weeks After Baseline	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

Name	Time	Method
Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline	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 8 Weeks After Baseline	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 20 Weeks After Baseline	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 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 4 Weeks After Baseline	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 24 Weeks After Baseline	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).
Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline	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).

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States