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Case Series/Study
Millions of patients globally are impacted by difficult-to-heal wounds, imposing a substantial burden on healthcare resources1. Effectively addressing these wounds is crucial. Skin substitutes emerge as a promising treatment option, providing the necessary structural elements and growth factors for re-epithelialization and revascularization2. Among these substitutes, amnion membrane (dHAM) allografts stand out as particularly promising, intended to repair tissue deficits and expedite healing for chronic and post-surgical wounds3. Despite their potential, there is a scarcity of published studies investigating the use of these grafts. This study aims to delve into the potential of skin substitutes, with a specific focus on dHAM allografts, utilizing mobile multispectral near-infrared spectroscopy (NIRS) and thermal imaging. The primary emphasis is on quantification of dHAM allografts impact on health outcomes.
Methods:
Using an FDA cleared class II medical device, handheld mobile multispectral near-infrared spectroscopy (NIRS) and thermal imaging device*, measurements of temperature and tissue oximetry (StO2) were performed. This case series evaluates the effectiveness of an FDA-cleared skin substitute product** on the healing rate of chronic non-healing wounds. Patients were longitudinally tracked to observe the healing trajectory, and relevant data, including demographics, clinical characteristics, and NIRS findings, were collected and analyzed.
Results:
NIRS imaging provided a comprehensive visualization and documentation of the healing trajectory, capturing variations in tissue oximetry and temperature. The visualization of angiogenesis processes via NIRS imaging provided insights into the intricate mechanisms underlying successful wound closure. Pre-operative assessments of the wound area were also conducted to determine blood flow adequacy in the wound bed, serving as a key investigational parameter for assessing the viability of accepting the skin substitute.
Discussion:
The management of difficult-to-heal wounds using dHAM highlights the regenerative potential of medicine in wound care. Mobile NIRS holds promise for assessing wound progression, appraising treatment efficacy, and pinpointing potential complications or impediments to healing. The integration of mobile NIRS imaging in post-application patient monitoring of skin substitutes provides healthcare professionals with invaluable insights. NIRS stands poised to assume a pivotal role in quantifying healing by measuring StO2 levels and offering visual insights into the intricate processes of angiogenesis. This case study also underscores the significance of collaborative efforts from a multidisciplinary team, which can significantly improve patient outcomes and enhance their overall quality of life. Nevertheless, further research is imperative to refine optimal practices for managing difficult-to-heal wounds.