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Trauma-related complications, such as haemodynamic or septic shock, are frequently observed in extensive burns and other major trauma. Such complexity presents substantial obstacles to generating statistically robust and reliable outcomes, either because a consistent patient cohort is difficult to find, or extensive stratification may be necessary when different cohorts of patients with different types of lesions are put together into a single trial population. This article highlights several of the methodological and operational challenges that can arise when conducting a wound care study and tries to create some upfront awareness of the pitfalls for such studies. The author has been a chief medical officer and independent consultant to the wound care industry for &gt;35 years, and some statements in this article are based on his personal experience and observations.<\/jats:p>","DOI":"10.12968\/jowc.2025.0043","type":"journal-article","created":{"date-parts":[[2026,2,6]],"date-time":"2026-02-06T17:24:55Z","timestamp":1770398695000},"page":"187-192","source":"Crossref","is-referenced-by-count":0,"title":["Clinical studies in wound care are not easy: some remarks and personal observations"],"prefix":"10.12968","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7860-5136","authenticated-orcid":false,"given":"Michel HE","family":"Hermans","sequence":"first","affiliation":[{"name":"Hermans Medical Consulting, Smetanahof 41, 1628 SR Hoorn, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"5130","reference":[{"key":"e_1_3_2_1_2","doi-asserted-by":"publisher","DOI":"10.1089\/wound.2021.0026"},{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12683"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.35077"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2018.02.023"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41581-019-0244-2"},{"key":"e_1_3_2_6_2","unstructured":"Center for Disease Control. 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