Trial Outcomes & Findings for Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns (NCT NCT01418482)

Results Overview

burns healed

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

3 weeks

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Mepilex Border Ag Mepilex Border Ag, a silver dressing
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepilex Border Ag n=15 Participants Mepilex Border Ag, ( a silver dressing)
Age, Continuous	44.5 years STANDARD_DEVIATION 14.5 • n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Region of Enrollment Sweden	15 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: small thickness partial burns

burns healed

Outcome measures

Outcome measures
Measure	Mepilex Border Ag n=15 Participants Mepilex Border Ag
Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice	9 burns healed

SECONDARY outcome

Timeframe: 3 weeks

Comfort level and overall experience were each assessed using a scale that ranged from very poor to very good.

Outcome measures

Outcome measures
Measure	Mepilex Border Ag n=15 Participants Mepilex Border Ag
Evaluate the Comfort Conformability Good -very Good	15 participants
Evaluate the Comfort Overall experience good-very good	14 participants

SECONDARY outcome

Timeframe: 3 weeks

To evaluate pain during dressing removal at visit 4,(after one week) with John Hopkins pain scale. Measured 0=no pain, 100= worst pain, scale from 0-100 mm

Outcome measures

Outcome measures
Measure	Mepilex Border Ag n=15 Participants Mepilex Border Ag
Pain	0 units on a scale Interval 0.0 to 40.0

Adverse Events

Mepilex Border Ag

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mepilex Border Ag n=15 participants at risk Mepilex Border Ag
General disorders Swelling of left hand	6.7% 1/15 • Number of events 1
Infections and infestations Infection left arm, no study burn	6.7% 1/15 • Number of events 1

Additional Information

Fredrik Huss

Uppsala Akademiska Hospital, Dept. of Plastic Surgery

Phone: +46 771 405 405

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60