NCT03815240

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

Comparing the Effects of Three Different Dressings on the Cutaneous Response to Pressure and Shear of Sacral Skin: an Exploratory Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 65 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pressure Ulcer Prevention

Interventions

Type	Name	Description
OTHER	No dressing	no dressing at sacrum
OTHER	Mepilex® Border Sacrum	adhesive sacrum dressing
OTHER	ALLEVYN Life Sacrum	adhesive sacrum dressing
OTHER	Optifoam® Gentle Sacrum	adhesive sacrum dressing

Timeline

• Start date: 2019-02-08
• Primary completion: 2019-07-23
• Completion: 2019-07-23
• First posted: 2019-01-24
• Last updated: 2020-05-06
• Results posted: 2020-05-06

Locations

1 site across 1 country: Germany