(EBP-003) Textile Composition, Not Number of Layers, Impact Interphase Pressure (IP): A Pragmatic, Comparative Analysis of the IP of Seven Different Two Layer Cohesive Bandage Kits in Healthy Volunteers
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<b>Introduction</b>: <p class="MsoNormal"><span style="mso-ascii-font-family: Calibri; mso-hansi-font-family: Calibri; mso-bidi-font-family: Calibri; color: black; background: white;">Compression is an integral part of the conventional management of chronic venous disease (CVD), venous leg ulcers (VLU) and edema of any origin.</span><sup><span style="mso-spacerun: yes;">1-4</span></sup> Review of the literature for evidence to differentiate between compression applications leaves clinicians perplexed as to how to discriminate between compression bandage kits which are marketed as equivocal based on the number of layers.<span style="mso-spacerun: yes;"> </span>The aim of this research project was to document the <em>in vivo</em> IP produced, immediately upon application, of the seven, ‘two-layer cohesive’ compression bandage kits.</p> <span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"><span style="font-size: 11pt;"><br /></span></span><br/><br/><b>Methods</b>: <p class="MsoNormal">A sample of convenience was utilized (n=10).<span style="mso-spacerun: yes;"> </span>Compression bandages were applied in random order, on non-consecutive days over a 4-week period. IP measurements were measured at two locations on the leg (B1 and C), with the volunteer in two positions (supine and standing). This procedure was repeated twice on the same volunteer, for each compression bandage kit.<br /><span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">ANOVA was utilized to assess the effects of the bandage type on IP for each of the measurement points and according to the subject’s position.<span style="mso-spacerun: yes;"> </span>Post hoc analyses were performed by Tukey and Bonferroni to identify significant differences.<span style="mso-spacerun: yes;"> </span>A regression model including the main effect of the wrap and the subject was performed.</span></p><br/><br/><b>Results</b>: The<span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"> <em>in vivo</em> IP measured at B1 in the supine position varied from 50.1mmHg (</span><span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">±</span><span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">5.33) to 73.70mmHg (</span><span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-theme-font: minor-latin; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">±</span><span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">13.44). <span style="mso-spacerun: yes;"> </span>Bonferroni post hoc analyses, with 95% Confidence Interval, found significant differences between wraps and placed them into 5 groups. A regression model including the main effects of wrap and subject with their interaction had an R<sup>2</sup>=0.881.</span><br/><br/><b>Discussion</b>: Compression applications composed of the same number of layers are viewed as comparable. Results of this <em>in vivo</em> study demonstrated that there is a statistically significant difference between IP achieved at the time of initial applications between the compression bandage kits. The clinical impact of these differences is not known. Review of the literature demonstrates that <em>in vivo </em>compression dosage is not consistently documented in research studies. Based on the findings of this independent review, one could hypothesize that outcomes of one two-layer product can NOT be generalized to another two layer product. In summary, all two layer cohesive wraps may not produce the same therapeutic effect as they are composed of different types of textile components. Additional study, inclusive of <em>in vivo</em> IP measurements, is necessary in order for clinicians to practice an evidence based approach to compression selection.<br/><br/><b>Trademarked Items</b>: <br/><br/><b>References</b>: 1. Shi C, Dumville JC, Cullum N, Connaughton E, Norman G. Compression bandages or stockings versus no compression for treating venous leg ulcers. Cochrane Database Syst Rev. Jul 26 2021;7(7):Cd013397. doi:10.1002/14651858.CD013397.pub2 2. Dissemond J, Assenheimer B, Bültemann A, et al. Compression therapy in patients with venous leg ulcers. JDDG: Journal der Deutschen Dermatologischen Gesellschaft. 2016;14(11):1072-1087. doi:https://doi.org/10.1111/ddg.13091 3. Stout N, Partsch H, Szolnoky G, et al. Chronic edema of the lower extremities: international consensus recommendations for compression therapy clinical research trials. Int Angiol. Aug 2012;31(4):316-29. 4. Gianesini S, Obi A, Onida S, et al. Global guidelines trends and controversies in lower limb venous and lymphatic disease: Narrative literature revision and experts' opinions following the vWINter international meeting in Phlebology, Lymphology & Aesthetics, 23-25 January 2019. Phlebology. Sep 2019;34(1 Suppl):4-66. doi:10.1177/0268355519870690<br/><br/>