Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin
Condition: Pressure Ulcer Prevention
MeSH terms: Pressure Ulcer
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): No dressing; Mepilex® Border Sacrum; ALLEVYN Life Sacrum; Optifoam® Gentle Sacrum
Intervention type(s): Other; Other; Other; Other
Intervention description(s): no dressing at sacrum; adhesive sacrum dressing; adhesive sacrum dressing; adhesive sacrum dressing
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pressure Ulcer Prevention; Preventive Dressings