Trial Outcomes & Findings for An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver. (NCT NCT01734317)
NCT ID: NCT01734317
Last Updated: 2020-04-03
Results Overview
Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.
COMPLETED
NA
10 participants
14 days and 21 days
2020-04-03
Participant Flow
Participant milestones
| Measure |
Dressing
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: A soft silicone wound contact layer.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.
Baseline characteristics by cohort
| Measure |
Mepilex Transfer Ag
n=10 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 18.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 14 days and 21 daysHealing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.
Outcome measures
| Measure |
Dressing
n=10 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: A soft silicone wound contact layer.
|
|---|---|
|
Number of Participants With Wound Healing
|
10 participants
|
SECONDARY outcome
Timeframe: After 0/14/21 days treatmentPopulation: No data collected
Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right. Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal
Outcome measures
Outcome data not reported
Adverse Events
Dressing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER