Validation of the suction device Nimble for the assessment of skin fibrosis in systemic sclerosis

Abstract

Objectives: Skin fibrosis is a main hallmark of systemic sclerosis (SSc). Clinical assessment is done semi-quantitatively using the modified Rodnan skin score (mRSS). Objective measurements for quantifying skin fibrosis could complement the mRSS to achieve higher reproducibility. The aim of this study was to explore the potential of suction measurements to detect structural changes in the skin that are associated with skin fibrosis. Methods: This clinical trial included 30 SSc patients and 30 healthy volunteers (HC). We validated a novel suction devicethe Nimble-to quantify skin stiffness in comparison to the Cutometer using the OMERACT filter. Results: A significant difference (p < 0.05) between the skin stiffness of HC and SSc patient groups was found for each location measured. The correlation between the measurements of forearm skin stiffness and the mRSS values was high for the Nimble (r = 0.82) and moderate for the Cutometer (r = 0.58). A ROC analysis showed good ability for the Nimble to distinguish between SSc patients with and without skin involvement (AUC = 0.82). Both suction devices provided excellent reliability in all measurements on HC and SSc patients and proved face validity and feasibility. Conclusion: Suction devices assessing skin stiffness, such as the Nimble, show clear potential to objectively quantify skin fibrosis in SSc patients and might be promising outcome measures complementing established methods such as the mRSS.

Skin mechanical properties measured with skin elasticity measurement device in patients with lymphedema: Scoping review

“…The application of skin elasticity meters for measuring skin mechanical properties has been insufficiently addressed in the literature for an extended period despite its demonstrated value in diverse fields, particularly in clinical medicine. 6 , 7 , 8 , 9 The predominance of palpatory assessments, such as “pitting edema,” 21 in the clinical management of lymphedema, may account for the limited use of skin elasticity meters for assessing skin mechanical properties in patients with lymphedema. Currently, a standardized protocol for objective measurement does not exist.…”

“… 3 Moreover, it has been applied in several studies within the cosmetic industry, 4 , 5 as well as in clinical settings for various skin diseases. 6 , 7 , 8 , 9 …”

A quantitative comparison of devices for in vivo biomechanical characterization of human skin

“…Consequently, the device can be operated with small contact forces, greatly improving the reliability of the measurements [ 17 ]. It has been successfully applied in numerous preclinical and clinical studies, such as for assessing the severity of skin fibrosis and for longitudinal monitoring of scar maturation in pediatric burn patients [ 18 – 20 ].…”

Systemic sclerosis in adults. Part II: management and therapeutics

“…Cutometer measurements correlate reasonably well with the mRSS, 11 and newer devices have been developed more recently to lessen the potential for interobserver technique variability. [11][12][13] As quantitative outcome measures, these tools are ideal as complementary outcome measures in the clinical trial setting, where reproducibility and consistency across multiple assessors is essential. 9…”