Trial Outcomes & Findings for Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries. (NCT NCT01439074)

NCT ID: NCT01439074

Last Updated: 2017-12-18

Results Overview

Healing will be defined as number of days

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 162 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2017-12-18

Participant Flow

Participant milestones

Measure	Mepilex Ag Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex Ag: Dressing	SSD Ag Cream Silver Sulphadiazine Ag cream Silver sulphadiazine: Cream
Overall Study STARTED	75	87
Overall Study COMPLETED	66	74
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Measure	Mepilex Ag Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex Ag: Dressing	SSD Ag Cream Silver Sulphadiazine Ag cream Silver sulphadiazine: Cream
Overall Study Lost to Follow-up	3	4
Overall Study Subject shedding	1	0
Overall Study Withdrawal by Subject	1	5
Overall Study Other	4	4

Baseline Characteristics

Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.

Baseline characteristics by cohort

Measure	Mepilex Ag n=71 Participants Mepilex Ag consists of a Safetac® soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex Ag: Dressing	SSD Ag Cream n=82 Participants Silver Sulphadiazine Ag white cream, 1% SSD Ag, 40g/tube Silver sulphadiazine: Cream	Total n=153 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=5 Participants	76 Participants n=7 Participants	144 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.0 years STANDARD_DEVIATION 12.3 • n=5 Participants	35.4 years STANDARD_DEVIATION 13.2 • n=7 Participants	36.2 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	25 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Region of Enrollment China	71 participants n=5 Participants	82 participants n=7 Participants	153 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.

Healing will be defined as number of days

Outcome measures

Measure	Mepilex Ag n=71 Participants Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex Ag: Dressing	SSD Ag Cream n=82 Participants Silver Sulphadiazine Ag cream Silver sulphadiazine: Cream
Time to Healing	16 days Standard Deviation 7.27	17 days Standard Deviation 6.39

SECONDARY outcome

Timeframe: 4 weeks

Healing will be defined as 95% or more epithelialisation

Outcome measures

Measure	Mepilex Ag n=71 Participants Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex Ag: Dressing	SSD Ag Cream n=82 Participants Silver Sulphadiazine Ag cream Silver sulphadiazine: Cream
Percent of Burn Epithelised/Healed	87.1 percentage of study burn healed Standard Deviation 29	85.2 percentage of study burn healed Standard Deviation 27.8

SECONDARY outcome

Timeframe: 4 weeks

Population: ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.

Number of dressing changes including first assembly

Outcome measures

Measure	Mepilex Ag n=71 Participants Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex Ag: Dressing	SSD Ag Cream n=82 Participants Silver Sulphadiazine Ag cream Silver sulphadiazine: Cream
Number of Dressing Changes	3.1 applications Standard Deviation 1.86	14.0 applications Standard Deviation 13.0

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Measure	Mepilex Ag n=71 Participants Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex Ag: Dressing	SSD Ag Cream n=82 Participants Silver Sulphadiazine Ag cream Silver sulphadiazine: Cream
% of Study Burn Healed After One Week	44.3 percentage of study burn healed Standard Deviation 37.4	27.0 percentage of study burn healed Standard Deviation 30.7

Adverse Events

Mepilex Ag

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SSD Ag Cream

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

Prof Xia, Zhaofan

Changhai Hospital of Shanghai

Phone: +86 2181873471

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place