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

NCT03815240 | Completed Results

• 1 other identifier: CRC-SP-A-32
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Ulcer Prevention

Keywords

Pressure Ulcer Prevention; Preventive Dressings

Outcome Measures

Primary Outcomes (7)

• Change in Skin Surface Temperature From Baseline

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

  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).

• Change in Stratum Corneum Hydration (SCH) From Baseline

  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.

  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).

• Change in Erythema Index (EI) From Baseline

  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.

  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).

• Change in Average Roughness (Rz) From Baseline

  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.

  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).

• Change in Arithmetic Average Roughness (Ra) From Baseline

  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.

  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).

• Change in Maximum Roughness (Rmax) From Baseline

  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.

  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).

• Change in Interleukin IL-1alpha Concentration From Baseline

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

  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).

Secondary Outcomes (3)

• Occurence of Sacral Pain

  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).

• Time Until First Reporting of Sacral Pain

  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).

• Change in Erythema Score From Baseline

  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).

Study Arms (4)

no dressing (A)

OTHER

No dressing will be applied at sacrum before 3.5 hours loading period in supine position

Other: No dressing

Mepilex (B)

ACTIVE COMPARATOR

'Mepilex® Border Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position

Other: Mepilex® Border Sacrum

Allevyn (C)

ACTIVE COMPARATOR

'ALLEVYN Life Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position

Other: ALLEVYN Life Sacrum

Optifaom (D)

ACTIVE COMPARATOR

'Optifoam® Gentle Sacrum' Dressing will be applied at sacrum before 3.5 hours loading period in supine position

Other: Optifoam® Gentle Sacrum

Interventions

No dressing OTHER

no dressing at sacrum

no dressing (A)

Mepilex® Border Sacrum OTHER

adhesive sacrum dressing

Mepilex (B)

ALLEVYN Life Sacrum OTHER

adhesive sacrum dressing

Allevyn (C)

Optifoam® Gentle Sacrum OTHER

adhesive sacrum dressing

Optifaom (D)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy female volunteers
• to 80 years
• Body Mass Index 18.5 to 29.9 kg/m2
• Non-smoker of at least one year (including electronic-cigarettes)
• Informed consent
• Being free of any clinical dermatosis in the investigational area
• Intact sacral skin without scars
• Skin phototype I, II, or III (according to Fitzpatrick)
• No regular use of leave-on products on the sacral skin
• Willing and able to fulfil the study requirements

You may not qualify if:

• Disability to maintain in supine or prone Position
• Acute diseases
• Known hyper-sensibility or allergy to the study product or any of its ingredients
• Use of topical treatment on the investigational areas or systemic Treatment within the 4 past weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, NSIDS etc.) that would interfere with assessment and/or investigational treatments
• Medical history of skin cancer
• History of established Diabetes mellitus, cardiac or renal insufficiency, COPD
• Chronic inflammatory skin disorders such as atopic dermatitis, psoriasis, lichen planus
• Participation in another study 4 weeks prior to study start

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Results Point of Contact

• Title: Dr. Jan Kottner
• Organization: Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin

jan.kottner@charite.de

+49 30 450 518218

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 24, 2019
• Study Start: February 8, 2019
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: May 6, 2020
• Results First Posted: May 6, 2020

Record last verified: 2020-04

Locations

DE (1)