NCT03815240

Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin

Completed NA Results posted Last updated 6 May 2020

What this trial tests

NA trial testing No dressing in Pressure Ulcer Prevention in 12 participants. Completed in 23 July 2019.

Timeline

8 February 2019

Primary endpoint
23 July 2019

23 July 2019

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	12
Start date	8 February 2019
Primary completion	23 July 2019
Estimated completion	23 July 2019
Sites	1 location across Germany

Drugs / interventions tested

• No dressing
• Mepilex® Border Sacrum
• ALLEVYN Life Sacrum
• Optifoam® Gentle Sacrum

Conditions studied

• Pressure Ulcer Prevention — all drugs for Pressure Ulcer Prevention →

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 65 to 80, female only, with Pressure Ulcer Prevention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Skin Surface Temperature From Baseline Primary · 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).

A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum

Group	Value	95% CI
no Dressing (A)	3.1	1.9 – 4.1
Mepilex (B)	3.8	2.8 – 4.1
Allevyn (C)	3.0	2.4 – 4.4
Optifaom (D)	3.3	2.3 – 3.9

Change in Stratum Corneum Hydration (SCH) From Baseline Primary · 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).

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.

Group	Value	95% CI
no Dressing (A)	7.0	0.7 – 13.3
Mepilex (B)	4.4	1.2 – 11.5
Allevyn (C)	5.9	-0.4 – 9.2
Optifaom (D)	7.3	3.6 – 15.0

Change in Erythema Index (EI) From Baseline Primary · 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).

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.

Group	Value	95% CI
no Dressing (A)	29	19 – 49
Mepilex (B)	7	-9 – 45
Allevyn (C)	41	-2 – 63
Optifaom (D)	4	-24 – 25

Change in Average Roughness (Rz) From Baseline Primary · 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).

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.

Group	Value	95% CI
no Dressing (A)	-0.8	-7.6 – 1.8
Mepilex (B)	-1	-5.3 – 2.8
Allevyn (C)	-0.8	-2.0 – 0.9
Optifaom (D)	-6.3	-9.4 – -5.0

Change in Arithmetic Average Roughness (Ra) From Baseline Primary · 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).

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.

Group	Value	95% CI
no Dressing (A)	-0.8	-3.9 – 2.4
Mepilex (B)	-0.3	-5.8 – 3.1
Allevyn (C)	0.5	-0.5 – 2.3
Optifaom (D)	-4.5	-6.9 – -0.6

Change in Maximum Roughness (Rmax) From Baseline Primary · 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).

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.

Group	Value	95% CI
no Dressing (A)	-0.5	-8.8 – 2.6
Mepilex (B)	-1.8	-7.8 – 2.4
Allevyn (C)	-1.3	-3.1 – 1.0
Optifaom (D)	-8.0	-12.3 – -5.1

Change in Interleukin IL-1alpha Concentration From Baseline Primary · 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).

Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations.

Group	Value	95% CI
no Dressing (A)	1.1	-0.1 – 4.2
Mepilex (B)	-0.1	-0.9 – 2.5
Allevyn (C)	1.3	0.1 – 3.7
Optifaom (D)	1.3	-0.8 – 2.8

Occurence of Sacral Pain Secondary · 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).

The occurrence of pain (yes/no)

Group	Value	95% CI
no Dressing (A)	0
Mepilex (B)	0
Allevyn (C)	0
Optifoam (D)	0

Time Until First Reporting of Sacral Pain Secondary · 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).

Time from baseline until the subject reported pain at sacrum

Group	Value	95% CI
no Dressing (A)	NA	NA – NA
Mepilex (B)	NA	NA – NA
Allevyn (C)	NA	NA – NA
Optofoam (D)	NA	NA – NA

Change in Erythema Score From Baseline Secondary · 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)

Group	Value	95% CI
no Dressing (A)	9
Mepilex (B)	6
Allevyn (C)	5
Optifaom (D)	5
no Dressing (A)	3
Mepilex (B)	6
Allevyn (C)	6
Optifaom (D)	5
no Dressing (A)	0
Mepilex (B)	0
Allevyn (C)	1
Optifaom (D)	2

Sponsor's own description

Skin functional parameters such as erythema or stratum corneum hydration have been successfully used in PU prevention research. These parameters are able to discriminate effects of different loading intensities and to measure PU preventive device performance.

The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on the skin structure and function during mechanical loading compared to (1) no dressing, (2) ALLEVYN Life Sacrum Dressing and (3) Optifoam® Gentle Liquitrap Sacrum Dressing.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.