Trial Outcomes & Findings for An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients (NCT NCT01670201)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

10 days

Results posted on

2014-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Mepilex Transfer Ag Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepilex Transfer Ag n=8 Participants Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Region of Enrollment United States	8 participants n=93 Participants

PRIMARY outcome

Timeframe: 10 days

Outcome measures

Outcome measures
Measure	Mepilex Transfer Ag n=8 Participants Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing
Percentage of Participants Who Had > 95 % Epithelialization at Day 10	0 percentage of participants

SECONDARY outcome

Timeframe: 28 days

The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days. Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS), Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst.

Outcome measures

Outcome measures
Measure	Mepilex Transfer Ag n=8 Participants Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing
Pain at Dressing Changes	6.0 units on a scale VAS 0-100 Interval 0.0 to 44.0

Adverse Events

Mepilex Transfer Ag

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mepilex Transfer Ag n=8 participants at risk Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing
Skin and subcutaneous tissue disorders Worsening disruption of wound healing	12.5% 1/8 • Number of events 1

Other adverse events

Other adverse events
Measure	Mepilex Transfer Ag n=8 participants at risk Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: Silver dressing
Skin and subcutaneous tissue disorders Infection to donor site	12.5% 1/8 • Number of events 1

Additional Information

Dr Nicole Gibran

Harborview Medical Center / Seattle, Washington

Phone: 206-744-3140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60