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. 2025:2922:335-354.
doi: 10.1007/978-1-0716-4510-9_26.

Standardized Outcome Measures for the Clinical Application of Tissue Engineered Products

Anna S van den Bosch  1   2   3 , Melinda Farkas  4   5   6 , Frederique M Kemme  1   2   3 , Matthea M Stoop  1   2 , Paul P M van Zuijlen  1   2   3   7 , Annebeth Meij-de Vries  1   7   8 , Esther Middelkoop  1   2   3 , Anouk Pijpe  9   10   11
Affiliations

Standardized Outcome Measures for the Clinical Application of Tissue Engineered Products

Anna S van den Bosch et al. Methods Mol Biol. 2025.

Abstract

The clinical application of tissue engineered products aims to regenerate skin and enhance the appearance, texture, sensation, and functionality of affected skin or scars. To evaluate the efficacy and effectiveness of novel products, level 1 randomized controlled trials are required. However, currently a significant challenge in this field is the clinical and statistical heterogeneity of trial designs and outcome measures for tissue engineered products. To address this challenge and improve clinical outcomes, it is essential to standardize high-quality outcome measures. These measures are clinimetrically developed tools designed to reliably and validly assess specific health outcomes across diverse patient populations, clinical settings, and studies. This chapter proposes a core set of outcome measurements designed to evaluate the most relevant, feasible, reliable, and valid parameters in the clinical application of tissue engineered products. For routine clinical practice, we recommend the inclusion of photography, graft take, re-epithelialization, and scar quality assessment using the Patient and Observer Scar Assessment Scale. For clinical trials, additional measures such as colorimetry and elasticity assessment are advised. Detailed protocols for these methods are provided, resulting in a standardized core outcome set. High-quality outcome assessment also necessitates specialized training and the presence of trained personal at all assessment points. The chapter further addresses specific considerations for outcome assessment in pediatric patients, remote assessment strategies, and additional recommendations for optimizing clinical and research practices in this field. The implementation of standardized outcome measurement is essential for improving the outcomes of patients treated with tissue engineered products.

Keywords: Clinical trials; Outcome assessment; Scar quality; Skin regeneration; Tissue engineering.

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