Comparison of “Semiocclusive Dressing” Treatment Using Plastic Wrap or Low-Adherent Absorbent Wound Dressings Versus Occlusive Dressing Treatment for Stage II Pressure Injuries: A Randomized, Controlled, Noninferiority Trial

<b>Objective:</b> To verify the noninferiority of the effectiveness of "semiocclusive dressing" (SOD) treatment using plastic wrap or low-adherent absorbent wound dressings compared with occlusive dressing (OD) treatment for National Pressure Injury Advisory Panel stage II pressure injuries. <b>Approach:</b> This 12-week, open-label, randomized, controlled, noninferiority trial was conducted at one hospital and three care facilities. Of the 115 participants, 56 were assigned to SOD treatment and 59 to OD treatment. The study design adhered to the CONSORT 2010 extension statement for noninferiority trials. The primary outcome was a comparison of the healing times for both treatments, with the noninferiority margin set at 7.0 days. Secondary outcomes included treatment costs, Kaplan-Meier curves, and incidence of adverse events. <b>Results:</b> The mean healing times for SOD and OD treatments were 19.7 and 22.5 days, respectively (<i>p</i> = 0.4175). The 95% confidence interval of the difference was -4.0 to 9.6. Since its lower limit was within the noninferiority margin, SOD treatment was confirmed to be not significantly worse than OD treatment. OD treatment had a significantly higher mean cost than SOD treatment (<i>p</i> < 0.0001). Kaplan-Meier curves for both groups were similar (<i>p</i> = 0.249). The incidence of adverse events in both groups was comparable. <b>Innovation:</b> Uniquely, the SOD does not tightly adhere to or completely occlude the wound and can manage abundant exudate. Therefore, SOD treatment maintains an adequately moist environment to facilitate wound healing. <b>Conclusion:</b> SOD treatment was more cost-effective than OD treatment for stage II pressure injuries. [Figure: see text].