Trial Outcomes & Findings for A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers (NCT NCT03903692)

Results Overview

Evaluate and compare the percent change in wound size from first to last visit; therefore, percentage change in wound area (mean (t-test) and median (Mann-Whitney U-test)) from first to last visit was calculated for comparison

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

Baseline to 56 days

Results posted on

2024-06-25

Participant Flow

13 subjects were withdrawn from the study and 6 subjects had unusable data. The analysis was performed on the remaining 43 subjects.

Participant milestones

Participant milestones
Measure	Marine Polysaccharide Dressing Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.	Carboxymethylcellulose Dressing Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.
Overall Study STARTED	23	20
Overall Study COMPLETED	23	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Marine Polysaccharide Dressing n=23 Participants Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.	Carboxymethylcellulose Dressing n=20 Participants Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.	Total n=43 Participants Total of all reporting groups
Age, Continuous	65.30 years STANDARD_DEVIATION 13.14 • n=5 Participants	66.75 years STANDARD_DEVIATION 11.20 • n=7 Participants	65.98 years STANDARD_DEVIATION 12.15 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 56 days

Evaluate and compare the percent change in wound size from first to last visit; therefore, percentage change in wound area (mean (t-test) and median (Mann-Whitney U-test)) from first to last visit was calculated for comparison

Outcome measures

Outcome measures
Measure	Marine Polysaccharide Dressing n=23 Participants Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.	Carboxymethylcellulose Dressing n=20 Participants Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.
Percent Change in Wound Size From Baseline	45.61 % change in wound area Standard Deviation 36.76	56.41 % change in wound area Standard Deviation 61.43

SECONDARY outcome

Timeframe: Baseline to 56 days

peri-ulcer skin assessment scale is used for assessment. There are 9 systemically items edema, erythema, white atrophy, venous pigmentation, papulovesicular erythema, hyperkeratosis, purpuric patches, telengiectasis, \& itching lesions. Each is measured for an extension score 0-4 (0=none; 1=punctual, no extension; 2=local, no extension, does not include total ulcer perimeter; 3=includes total ulcer perimeter, does not include spread beyond; 4=spreads beyond total ulcer perimeter) \& severity score from 0-3 (=-none; 1=only detected following examination; 2=clearly apparent; 3=as evident as the wound). The global score is the extension score multiplied by the severity score. Global scores are added together to a total score. Total score scale range 0 - 70 with 0 being the best score and 70 being the worst. All sub-score values, 0 is best score; higher values indicate worsening wounds.

Outcome measures

Outcome measures
Measure	Marine Polysaccharide Dressing n=23 Participants Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.	Carboxymethylcellulose Dressing n=20 Participants Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.
Evaluation of Peri-ulcer Skin Assessment Scale	23.5 Score on a scale Standard Deviation 18.15	24.39 Score on a scale Standard Deviation 18.77

SECONDARY outcome

Timeframe: Baseline to 56 days

Population: All participants at all dressing changes.

Pain was assessed at each dressing change over the course of the study on a scale of 0-10 with 0 being no pain and 10 being the worst pain. The pain score reported was the average of all scores taken at each dressing change for all patients from baseline to 56 days.

Outcome measures

Outcome measures
Measure	Marine Polysaccharide Dressing n=23 Participants Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.	Carboxymethylcellulose Dressing n=20 Participants Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.
Score on a Pain Scale.	1.50 Score on a scale Standard Deviation 2.46	1.65 Score on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: Baseline to 56 days

Population: Percent change was calculated as the area of the dressing at time of application minus the area of the dressing at time of removal, divided by the area of the dressing at time of application, times 100.

Outcome measures

Outcome measures
Measure	Marine Polysaccharide Dressing n=23 Participants Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.	Carboxymethylcellulose Dressing n=20 Participants Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.
Change in Surface Area of the Dressing	0.76 Percent change Standard Deviation 42.11	12.65 Percent change Standard Deviation 48.99

Adverse Events

Marine Polysaccharide Dressing

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Carboxymethylcellulose Dressing

Serious events: 2 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Marine Polysaccharide Dressing n=23 participants at risk Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.	Carboxymethylcellulose Dressing n=20 participants at risk Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.
Musculoskeletal and connective tissue disorders Serious Adverse Event	4.3% 1/23 • Number of events 1 • 8 weeks	0.00% 0/20 • 8 weeks
Respiratory, thoracic and mediastinal disorders Serious Adverse Event	4.3% 1/23 • Number of events 1 • 8 weeks	0.00% 0/20 • 8 weeks
Renal and urinary disorders All-Cause Mortality	0.00% 0/23 • 8 weeks	5.0% 1/20 • Number of events 1 • 8 weeks
Gastrointestinal disorders Serious Adverse Event	0.00% 0/23 • 8 weeks	5.0% 1/20 • Number of events 1 • 8 weeks

Other adverse events

Other adverse events
Measure	Marine Polysaccharide Dressing n=23 participants at risk Marine polysaccharide dressing: The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.	Carboxymethylcellulose Dressing n=20 participants at risk Carboxymethylcellulose dressing: The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.
Skin and subcutaneous tissue disorders Adverse Event	4.3% 1/23 • Number of events 1 • 8 weeks	5.0% 1/20 • Number of events 1 • 8 weeks
Blood and lymphatic system disorders Adverse Event	8.7% 2/23 • Number of events 2 • 8 weeks	0.00% 0/20 • 8 weeks
Surgical and medical procedures Adverse Event	34.8% 8/23 • Number of events 8 • 8 weeks	25.0% 5/20 • Number of events 5 • 8 weeks
Gastrointestinal disorders Adverse Event	0.00% 0/23 • 8 weeks	15.0% 3/20 • Number of events 3 • 8 weeks
Infections and infestations Adverse Event	4.3% 1/23 • Number of events 1 • 8 weeks	10.0% 2/20 • Number of events 2 • 8 weeks
Respiratory, thoracic and mediastinal disorders Adverse Event	4.3% 1/23 • Number of events 1 • 8 weeks	0.00% 0/20 • 8 weeks
Renal and urinary disorders Adverse Event	0.00% 0/23 • 8 weeks	5.0% 1/20 • Number of events 1 • 8 weeks

Additional Information

Julie Miller

Medline Industries, LP

Phone: 630-418-6891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60