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

Charité University Medicine Berlin

Status: Completed

Conditions: Pressure Ulcer Prevention

Treatments: Other: Optifoam® Gentle Sacrum; Other: Mepilex® Border Sacrum; Other: ALLEVYN Life Sacrum; Other: No dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03815240

CRC-SP-A-32

Details and patient eligibility

About

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.

Full description

Pressure ulcers (PUs) are severe and unwanted cutaneous lesions and subcutaneous wounds caused by prolonged skin and underlying soft tissue deformation. In the supine position they predominantly occur near to bony prominences, like at the sacral area. The cornerstone of PU prevention is repositioning, early mobilization and the use of special support surfaces. In addition, empirical evidence suggests that the application of preventive dressings on PU predilection sites helps to prevent PU development.

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. Recently it could be shown that there are associations between structural and functional skin changes at the sacral area during loading. 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 no dressing, ALLEVYN Life Sacrum and Optifoam® Gentle Liquitrap Sacrum.

The procedure of one visit will be as follows:

After a skin acclimatization time of 30 minutes baseline measurements and Cyanoacrylate Skin Surface (CSSS)-stripping will be performed. Then a randomization envelope will be opened and the corresponding dressing will be applied or the skin will be left uncovered. The subject will then lie in supine position on a standard hospital mattress for a loading period of 3.5 hours. Every 30 minutes the head of the bed will be elevated to 45° for five minutes. During these five minutes, the participants will be instructed to bend their knees and to drag the feet repeatedly forth and back 10 times in order to simulate shear forces. The whole exercise will be done six times, after 0.5, 1, 1.5, 2, 2.5 and 3 hours. After 3.5 hours loading time in supine position the subjects will move into prone position. The dressing (if present) will be removed and all skin measurements and CSSS-stripping will be conducted again. The subjects will come back for another three times completing the remaining interventions. At the end, each volunteer will have received all three types of dressings once and once no dressing. In between, there are at least 3 weeks to prevent possible carry over effects.

Enrollment: 12 patients

Sex: Female

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female volunteers
• 65 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

Exclusion criteria

• Disability to maintain in supine or prone Position
• Acute diseases
• Known hyper-sensibility or allergy to the study product or any of its ingredients
• Extensive UV exposure 4 weeks before study inclusion
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

no dressing (A)

Other group

Description:

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

Treatment:

Other: No dressing

Mepilex (B)

Active Comparator group

Description:

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

Treatment:

Other: Mepilex® Border Sacrum

Allevyn (C)

Active Comparator group

Description:

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

Treatment:

Other: ALLEVYN Life Sacrum

Optifaom (D)

Active Comparator group

Description:

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

Treatment:

Other: Optifoam® Gentle Sacrum