The execution of clinical trials in wound care significantly differs from, and is frequently more challenging than, those involving pharmaceutical agents. Populations presenting with wounds (such as trauma and ulcers) are typically heterogeneous, and often exhibit a range of comorbidities and secondary factors that influence both the nature of the lesion itself and the trajectory of wound healing. Typical comorbidities in patients with ulcers include diabetes and chronic obstructive pulmonary disease, and polypharmacy is common. 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 >35 years, and some statements in this article are based on his personal experience and observations.
Michel Hermans (Mon,) studied this question.