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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02001558
Enrollment
65
Registered
2013-12-05
Start date
2013-03-31
Completion date
2017-08-31
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer, Spinal Cord Injuries

Keywords

Spinal cord injuries, Pressure ulcer

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.

Interventions

DRUGMicrocyn

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

OTHERSterile 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

Sponsors

Oculus Innovative Sciences, Inc.
CollaboratorINDUSTRY
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline24 weeks after baselinePressure 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 Baselinepressure ulcer size (length x width x depth, cm^3) at baselinePressure 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 Baseline4 weeks after baselinePressure 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 Baseline8 weeks after baselinePressure 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 Baseline12 weeks after baselinePressure 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 Baseline16 weeks after baselinePressure 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 Baseline20 weeks after baselinePressure 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

MeasureTime frameDescription
Pressure Ulcer Scale for Healing (PUSH) Scoreat baselinePUSH 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 Baseline4 weeks after baselinePUSH 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 Baseline8 weeks after baselinePUSH 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 Baseline12 weeks after baselinePUSH 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 Baseline16 weeks after baselinePUSH 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 Baseline20 weeks after baselinePUSH 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 Baseline24 weeks after baselinePUSH 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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 for the earlier of total wound closure or Week 24
32
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 for the earlier of total wound closure or Week 24
33
Total65

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up814

Baseline characteristics

CharacteristicMicrocynTotalSterile Saline
Age, Continuous40.75 years
STANDARD_DEVIATION 13.37
39.98 years
STANDARD_DEVIATION 12.23
39.24 years
STANDARD_DEVIATION 11.17
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
20 Participants40 Participants20 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
12 Participants25 Participants13 Participants
Region of Enrollment
United States
32 participants65 participants33 participants
Sex: Female, Male
Female
7 Participants10 Participants3 Participants
Sex: Female, Male
Male
25 Participants55 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 320 / 33
other
Total, other adverse events
0 / 320 / 33
serious
Total, serious adverse events
0 / 320 / 33

Outcome results

Primary

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.

Time frame: 12 weeks after baseline

Population: Microcyn arm: there were 9 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 18 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline7.50 cm^3
Sterile SalinePressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline19.25 cm^3
Primary

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.

Time frame: 16 weeks after baseline

Population: Microcyn arm: there were 13 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline8.00 cm^3
Sterile SalinePressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline11.63 cm^3
Primary

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.

Time frame: 20 weeks after baseline

Population: Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 25 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline7.63 cm^3
Sterile SalinePressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline9.75 cm^3
Primary

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.

Time frame: 24 weeks after baseline

Population: Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline3.68 cm^3
Sterile SalinePressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline8.68 cm^3
Primary

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.

Time frame: 4 weeks after baseline

Population: Microcyn arm: there were 8 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 10 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline9.00 cm^3
Sterile SalinePressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline15.75 cm^3
Primary

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.

Time frame: 8 weeks after baseline

Population: Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 17 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline10.00 cm^3
Sterile SalinePressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline20.06 cm^3
Primary

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.

Time frame: pressure ulcer size (length x width x depth, cm^3) at baseline

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline10.13 cm^3
Sterile SalinePressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline21.00 cm^3
Secondary

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).

Time frame: at baseline

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Scale for Healing (PUSH) Score12.00 score on a scale
Sterile SalinePressure Ulcer Scale for Healing (PUSH) Score12.00 score on a scale
Secondary

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).

Time frame: 12 weeks after baseline

Population: Microcyn arm: there were 9 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline10.00 score on a scale
Sterile SalinePressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline11.50 score on a scale
Secondary

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).

Time frame: 16 weeks after baseline

Population: Microcyn arm: there were 13 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline12.00 score on a scale
Sterile SalinePressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline11.50 score on a scale
Secondary

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).

Time frame: 20 weeks after baseline

Population: Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 25 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline11.00 score on a scale
Sterile SalinePressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline10.50 score on a scale
Secondary

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).

Time frame: 24 weeks after baseline

Population: Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline10.50 score on a scale
Sterile SalinePressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline11.00 score on a scale
Secondary

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).

Time frame: 4 weeks after baseline

Population: Microcyn arm: there were 8 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 12 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline12.00 score on a scale
Sterile SalinePressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline11.00 score on a scale
Secondary

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).

Time frame: 8 weeks after baseline

Population: Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 17 participants lost to follow up during this evaluation period.

ArmMeasureValue (MEDIAN)
MicrocynPressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline11.00 score on a scale
Sterile SalinePressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline11.50 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026