Pilot-Study Lumina Switchable Post-Op Dressing & Postsurgical Wounds: A Non-interventional, Non-placebo-controlled, National Pilot Study

Abstract

Dressings applied to primarily closed surgical incisions should be appropriate interactive dressing [13] and demonstrate an ability to protect the wound from contaminants and trauma, manage exudate, and avoid excessive pressure to the incision line. Additionally, they should be flexible, well fixed to the skin on application, skin protective (e.g. reduce the risk of blistering or irritation, not excessively adhesive) and waterproof [14]. Film dressings were one of the first modern wound-dressing products. They are extremely flexible, transparent and adhesive. During the removal of the dressing skin stress occurs. An essential role are shearing and friction forces between skin and wound dressing playing. This problem includes missing elasticity, flexibility and too strong adhesion. A non-interventional, non-placebo-controlled, national pilot study was done to prove a new shearing force reducing technique and dressing. The used post-op dressing consists of a thin film backing with a switchable polyurethane adhesive and non-adhering absorption pad. Before removal the adhesion is reduced by illuminating the dressing with the UV-A lamp. 52 patients at a mean age of 55.79 years (SD±16.22) with a total of 52 wounds were included in the study, all of them finalized the 1-week study period. At baseline, pain was measured with a mean of 3.52 (SD±1.26), during the study period pain decreased to a mean of 2.10 (SD±0.97) (VAS 0=no pain, 10=excruciating pain). Significance was calculated as 0,000 (paired t-test). At each dressing change, pain level after dressing change was rated lower compared to the pain level before dressing change. Overall, pain level decreased over the study period. The removal of the dressing after illumination with the UV-A lamp was rated in mean with 1.79 (2. Visit) and 1.86 (3. Visit) on the 6-point-scale (1=very good -6=insufficient). Significance was calculated as 0,000 for visit 3 (one sample t-test [test value=3,0]). Reactions on the wound edge/wound surroundings have not been reported. In contrast, a reduction of maceration and redness of the wound edge/wound surrounding was observed. The results confirm that the adhesive ensures a safe and effective occlusion/fixation of the dressing and that the strong adhesion enables dressing to function according to specification. There was no deterioration of the wound situation or an infection in any of the cases. The switchable function of the adhesive allows the adhesion of the post-op dressing to the skin to be reduced when illuminated by the supplied UV-A lamp. The results of the present study show that the reduced adhesion upon illumination enables easy and comfortable removal of the dressing.