Trial Outcomes & Findings for A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns (NCT NCT01636362)

NCT ID: NCT01636362

Last Updated: 2014-10-07

Results Overview

\> = 95 % epitheliazation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Healing will be assessed after 14 days.
• Results posted on: 2014-10-07

Participant Flow

Participant milestones

Measure	Mepitel Ag Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Overall Study STARTED	45
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Mepitel Ag Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Overall Study Physician Decision	6
Overall Study Subject healed, not returning	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns

Baseline characteristics by cohort

Measure	Mepitel Ag n=45 Participants Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Age, Continuous	25 years n=5 Participants
Age, Categorical <=18 years	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Healing will be assessed after 14 days.

> = 95 % epitheliazation

Outcome measures

Measure	Mepitel Ag n=45 Participants Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Number of Subjects Healed at Day 14.	35 participants

PRIMARY outcome

Timeframe: Healing will be assessed after 21 days.

The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.

Outcome measures

Measure	Mepitel Ag n=37 Participants Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Proportion of Subjects Healed at Day 21.	37 participants

SECONDARY outcome

Timeframe: At day 21

Percent of study burn healed measured by PictZar photo analysis of tissue types.

Outcome measures

Measure	Mepitel Ag n=37 Participants Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Percent of Study Burn Healed.	97.1 percentage of healing Full Range 7,1 • Interval 75.6 to 100.0

Adverse Events

Mepitel Ag

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mepitel Ag n=45 participants at risk Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
Skin and subcutaneous tissue disorders Increased pain	2.2% 1/45 • Number of events 1
Infections and infestations Suspected cellulitis	2.2% 1/45 • Number of events 1

Additional Information

Joan Wilson

Molnlycke Health Care AB

Phone: 706 504 8997

Email: joan.wilson@molnlycke.com

Results disclosure agreements

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

Restriction type: OTHER