Trial Outcomes & Findings for Pressure Ulcer Healing With Microcyn (NCT NCT02001558)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

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

Results posted on

2018-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	32	33
Overall Study COMPLETED	24	19
Overall Study NOT COMPLETED	8	14

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	8	14

Baseline Characteristics

Pressure Ulcer Healing With Microcyn

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microcyn n=32 Participants 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	Sterile Saline n=33 Participants 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	Total n=65 Participants Total of all reporting groups
Age, Continuous	40.75 years STANDARD_DEVIATION 13.37 • n=5 Participants	39.24 years STANDARD_DEVIATION 11.17 • n=7 Participants	39.98 years STANDARD_DEVIATION 12.23 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	33 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Microcyn n=32 Participants 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	Sterile Saline n=33 Participants 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
Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline	10.13 cm^3 Interval 0.38 to 196.0	21.00 cm^3 Interval 0.23 to 269.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Microcyn n=24 Participants 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	Sterile Saline n=23 Participants 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
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline	9.00 cm^3 Interval 0.1 to 202.5	15.75 cm^3 Interval 0.0 to 160.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Microcyn n=20 Participants 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	Sterile Saline n=16 Participants 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
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline	10.00 cm^3 Interval 0.23 to 216.13	20.06 cm^3 Interval 0.0 to 165.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Microcyn n=23 Participants 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	Sterile Saline n=15 Participants 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
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline	7.50 cm^3 Interval 0.06 to 229.5	19.25 cm^3 Interval 0.0 to 224.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Microcyn n=19 Participants 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	Sterile Saline n=14 Participants 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
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline	8.00 cm^3 Interval 0.01 to 267.75	11.63 cm^3 Interval 0.01 to 123.75

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Microcyn n=20 Participants 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	Sterile Saline n=8 Participants 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
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline	7.63 cm^3 Interval 0.0 to 285.0	9.75 cm^3 Interval 0.0 to 72.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Microcyn n=20 Participants 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	Sterile Saline n=14 Participants 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
Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline	3.68 cm^3 Interval 0.05 to 200.0	8.68 cm^3 Interval 0.0 to 198.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Microcyn n=32 Participants 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	Sterile Saline n=33 Participants 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
Pressure Ulcer Scale for Healing (PUSH) Score	12.00 score on a scale Interval 4.0 to 15.0	12.00 score on a scale Interval 6.0 to 15.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Microcyn n=24 Participants 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	Sterile Saline n=21 Participants 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
Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline	12.00 score on a scale Interval 5.0 to 17.0	11.00 score on a scale Interval 2.6 to 16.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Microcyn n=20 Participants 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	Sterile Saline n=16 Participants 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
Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline	11.00 score on a scale Interval 6.0 to 15.0	11.50 score on a scale Interval 0.0 to 15.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Microcyn n=23 Participants 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	Sterile Saline n=14 Participants 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
Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline	10.00 score on a scale Interval 5.0 to 15.0	11.50 score on a scale Interval 0.0 to 15.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Microcyn n=19 Participants 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	Sterile Saline n=14 Participants 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
Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline	12.00 score on a scale Interval 2.0 to 14.0	11.50 score on a scale Interval 6.0 to 13.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Microcyn n=20 Participants 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	Sterile Saline n=8 Participants 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
Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline	11.00 score on a scale Interval 0.0 to 14.0	10.50 score on a scale Interval 0.0 to 14.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Microcyn n=20 Participants 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	Sterile Saline n=14 Participants 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
Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline	10.50 score on a scale Interval 4.0 to 15.0	11.00 score on a scale Interval 0.0 to 15.0

Adverse Events

Microcyn

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sterile Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yuying Chen, MD, PhD

University of Alabama at Birmingham

Phone: 205-934-3329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place