A single-center, prospective, randomized, open-label, clinical trial of ceramide 2-containing hydrocolloid dressings versus polyurethane film dressings for pressure ulcer prevention in high-risk surgical patients
Authors Kohta M, Sakamoto K, Kawachi Y, Oh-i T
Received 1 August 2015
Accepted for publication 20 September 2015
Published 6 November 2015 Volume 2015:2 Pages 171—179
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Mina Zarei
Peer reviewer comments 2
Editor who approved publication: Professor Marco Romanelli
Masushi Kohta,1 Kazumi Sakamoto,2 Yasuhiro Kawachi,3 Tsunao Oh-i4
1Medical Engineering Laboratory, ALCARE Co, Ltd, Tokyo, 2Department of Nursing, 3Department of Dermatology, Tokyo Medical University Ibaraki Medical Center, Ibaraki, 4Department of Dermatology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan
Purpose: There have been previous clinical studies regarding the impact of dressings on the prevention of pressure ulcer development. However, it remains unclear whether one type of dressing is better than any other type for preventing ulcer development during surgery. Therefore, we compared the effects of ceramide 2-containing hydrocolloid dressing with film dressings in high-risk patients with regard to reducing the incidence of pressure ulcer development during surgery.
Patients and methods: A prospective, randomized, open-label, clinical trial was conducted involving patients who were at a high risk of developing pressure ulcers at a Japanese hospital. The intervention group received ceramide 2-containing hydrocolloid dressings (n=66), and the control group received film dressings (n=64). The primary end point was the incidence rate of pressure ulcer development in both groups; skin damage, such as blanchable erythema, skin discoloration, contact dermatitis, and stripped skin, was recorded as the secondary end point. The relative risk (RR) and 95% confidence interval (CI) were assessed to compare the probability ratios of pressure ulcer development between the groups.
Results: There were significantly fewer patients who developed pressure ulcers in the intervention group than in the control group (RR, 0.37; 95% CI, 0.05–0.99; P=0.04). In the post hoc subgroup analysis, the superiority of the intervention group was more marked when patients had a lower body mass index (P=0.02), lower albumin values (P=0.07), and operation time of 3 hours or more and less than 6 hours (P=0.03). There was no evidence of any statistically significant differences in the types of skin damage reported.
Conclusion: Application of ceramide 2-containing hydrocolloid dressing reduced the risk of pressure ulcer development in patients who were at a high risk during surgery compared with film dressings.
Keywords: operating room, wound dressing, friction, skin protection, shear
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