Trial Outcomes & Findings for Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin (NCT NCT03815240)
NCT ID: NCT03815240
Last Updated: 2020-05-06
Results Overview
A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum
COMPLETED
NA
12 participants
Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
2020-05-06
Participant Flow
The study took place at the Clinical Research Center for Hair and Skin Science in Berlin, Germany from January 2019 to July 2019 and involved 12 healthy female volunteers
Participant milestones
| Measure |
No Dressing, Mepilex, Allevyn, Optifoam
Dressing application order:
no dressing (A), Mepilex® Border Sacrum (B), ALLEVYN Life Sacrum (C), Optifoam® Gentle Sacrum (D)
|
Mepilex, no Dressing, Optifoam, Allevyn
Dressing application order:
Mepilex® Border Sacrum (B), no dressing (A), Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C)
|
No Dressing, Mepilex, Optifoam, Allevyn
Dressing application order:
no dressing (A), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C)
|
No Dressing, Allevyn, Mepilex, Optifoam
Dressing application order:
no dressing (A), ALLEVYN Life Sacrum (C), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D)
|
Optifoam, Allevyn, no Dressing, Mepilex
Dressing application order:
Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C), no dressing (A), Mepilex® Border Sacrum (B)
|
Optifoam, Mepilex, Allevyn, no Dressing,
Dressing application order:
Optifoam® Gentle Sacrum (D), Mepilex® Border Sacrum (B), ALLEVYN Life Sacrum (C), no dressing (A)
|
Mepilex, Optifoam, no Dressing, Allevyn
Dressing application order:
Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D), no dressing (A), ALLEVYN Life Sacrum (C)
|
Allevyn, no Dressing, Mepilex, Optifoam
Dressing application order:
ALLEVYN Life Sacrum (C), no dressing (A), Mepilex® Border Sacrum (B), Optifoam® Gentle Sacrum (D)
|
Optifoam, Allevyn, Mepilex, no Dressing
Dressing application order:
Optifoam® Gentle Sacrum (D), ALLEVYN Life Sacrum (C), Mepilex® Border Sacrum (B), no dressing (A)
|
|---|---|---|---|---|---|---|---|---|---|
|
Intervention no Dressing
STARTED
|
2
|
1
|
1
|
2
|
1
|
2
|
1
|
1
|
1
|
|
Intervention no Dressing
COMPLETED
|
2
|
1
|
1
|
2
|
1
|
2
|
1
|
1
|
1
|
|
Intervention no Dressing
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Mepilex Dressing
STARTED
|
2
|
1
|
1
|
2
|
1
|
2
|
1
|
1
|
1
|
|
Intervention Mepilex Dressing
COMPLETED
|
2
|
1
|
1
|
2
|
1
|
2
|
1
|
1
|
1
|
|
Intervention Mepilex Dressing
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Allevyn Dressing
STARTED
|
2
|
1
|
1
|
2
|
1
|
2
|
1
|
1
|
1
|
|
Intervention Allevyn Dressing
COMPLETED
|
2
|
1
|
1
|
2
|
1
|
2
|
1
|
1
|
1
|
|
Intervention Allevyn Dressing
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Optifoam Dressing
STARTED
|
2
|
1
|
1
|
2
|
1
|
2
|
1
|
1
|
1
|
|
Intervention Optifoam Dressing
COMPLETED
|
2
|
1
|
1
|
2
|
1
|
2
|
1
|
1
|
1
|
|
Intervention Optifoam Dressing
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin
Baseline characteristics by cohort
| Measure |
no Dressing, Mepilex, Allevyn, Optifoam (in Different Order)
n=12 Participants
Cross-over study. Each of the 12 participants received each intervention once (no dressing, Mepilex® Border Sacrum, ALLEVYN Life Sacrum, Optifoam® Gentle Sacrum)
|
|---|---|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Change in Skin Surface Temperature From Baseline
|
3.0 °C
Interval 2.4 to 4.4
|
3.3 °C
Interval 2.3 to 3.9
|
3.1 °C
Interval 1.9 to 4.1
|
3.8 °C
Interval 2.8 to 4.1
|
PRIMARY outcome
Timeframe: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
Corneometer CM 825 (Courage and Khazaka Electronic GmbH) was used to measure the stratum corneum hydration (SCH) at the sacrum in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. The measurement is based on capacitance measurement of a dielectric medium. The change in the dielectric constant due to skin surface hydration by capacitance differences of a precision capacitor is measured.
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Change in Stratum Corneum Hydration (SCH) From Baseline
|
5.9 arbitrary units
Interval -0.4 to 9.2
|
7.3 arbitrary units
Interval 3.6 to 15.0
|
7.0 arbitrary units
Interval 0.7 to 13.3
|
4.4 arbitrary units
Interval 1.2 to 11.5
|
PRIMARY outcome
Timeframe: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
Mexameter MX18 (Courage and Khazaka Electronic GmbH) was used to measure the Erythema index at the sacrum. This device uses specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin) and presents values from 0 to 999. Lower values represent less redness.
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Change in Erythema Index (EI) From Baseline
|
41 arbitrary units
Interval -2.0 to 63.0
|
4 arbitrary units
Interval -24.0 to 25.0
|
29 arbitrary units
Interval 19.0 to 49.0
|
7 arbitrary units
Interval -9.0 to 45.0
|
PRIMARY outcome
Timeframe: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Change in Average Roughness (Rz) From Baseline
|
-0.8 micrometre
Interval -2.0 to 0.9
|
-6.3 micrometre
Interval -9.4 to -5.0
|
-0.8 micrometre
Interval -7.6 to 1.8
|
-1 micrometre
Interval -5.3 to 2.8
|
PRIMARY outcome
Timeframe: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Change in Arithmetic Average Roughness (Ra) From Baseline
|
0.5 micrometre
Interval -0.5 to 2.3
|
-4.5 micrometre
Interval -6.9 to -0.6
|
-0.8 micrometre
Interval -3.9 to 2.4
|
-0.3 micrometre
Interval -5.8 to 3.1
|
PRIMARY outcome
Timeframe: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Change in Maximum Roughness (Rmax) From Baseline
|
-1.3 micrometre
Interval -3.1 to 1.0
|
-8.0 micrometre
Interval -12.3 to -5.1
|
-0.5 micrometre
Interval -8.8 to 2.6
|
-1.8 micrometre
Interval -7.8 to 2.4
|
PRIMARY outcome
Timeframe: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations.
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Change in Interleukin IL-1alpha Concentration From Baseline
|
1.3 picogramme/microgramme
Interval 0.1 to 3.7
|
1.3 picogramme/microgramme
Interval -0.8 to 2.8
|
1.1 picogramme/microgramme
Interval -0.1 to 4.2
|
-0.1 picogramme/microgramme
Interval -0.9 to 2.5
|
SECONDARY outcome
Timeframe: Captured from baseline until the end of the loading period after 3.5 hours at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
The occurrence of pain (yes/no)
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Occurence of Sacral Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Sacral pain was assessed from baseline up until 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Population: Cross-over study. Each of the 12 participants received each intervention once (total number is 12).
Time from baseline until the subject reported pain at sacrum
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Time Until First Reporting of Sacral Pain
|
NA minutes
no participant experienced pain during the study visits
|
NA minutes
no participant experienced pain during the study visits
|
NA minutes
no participant experienced pain during the study visits
|
NA minutes
no participant experienced pain during the study visits
|
SECONDARY outcome
Timeframe: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).Erythema was assessed by visual inspection. A metric scale will be used: 0 = none 1 = mild (slight reddening), 2 = moderate (distinct redness), 3 = severe (strong redness, dark red)
Outcome measures
| Measure |
Allevyn (C)
n=12 Participants
'ALLEVYN Life Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
ALLEVYN Life Sacrum: adhesive sacrum dressing
|
Optifaom (D)
n=12 Participants
'Optifoam® Gentle Sacrum' Dressing was applied at sacrum before 3.5 hours loading period in supine position
Optifoam® Gentle Sacrum: adhesive sacrum dressing
|
no Dressing (A)
n=12 Participants
No dressing was applied at sacrum before 3.5 hours loading period in supine position
|
Mepilex (B)
n=12 Participants
'Mepilex® Border Sacrum' dressing was applied at sacrum before 3.5 hours loading period in supine position
|
|---|---|---|---|---|
|
Change in Erythema Score From Baseline
no erythema
|
5 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
|
Change in Erythema Score From Baseline
mild erythema
|
6 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
|
Change in Erythema Score From Baseline
moderate erythema
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
no Dressing (A)
Mepilex (B)
Allevyn (C)
Optifoam (D)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jan Kottner
Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place