Trial Outcomes & Findings for Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing (NCT NCT01214811)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

27 participants

Primary outcome timeframe

Baseline

Results posted on

2013-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Mepilex Border Ag Non comparative study with one active arm - Mepilex Border Ag Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
Overall Study STARTED	27
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepilex Border Ag n=27 Participants Non comparative study with one active arm - Mepilex Border Ag Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age Continuous	57.3 years STANDARD_DEVIATION 17.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After one week

At each visit the wound length and width is measured and calculated in cm2.

Outcome measures

Outcome measures
Measure	Mepilex Border Ag n=27 Participants Non comparative study with one active arm - Mepilex Border Ag Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
Wound Area at Visit 2	43.0 cm2 Standard Deviation 41.6

Adverse Events

Mepilex Border Ag

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

Viktoria Ahlenius Körner

Molnlycke Health Care

Phone: 0046 31 7223000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place