ABSTRACT
OBJECTIVE: To evaluate the performance of a rapid, point-of-care diagnostic biomarker that is sensitive to overexpression of gelatinases, the major expressed biomolecules during wound infection. Wound exudate composition and pH are key determinants of infection, and rapid infection detection has an important role in wound healing.
METHODS: The biomarker was first investigated for cytotoxic effects, and irritation and sensitization tests were carried out. The biomarker was then tested on 198 patients suffering from different types of wounds. Data including age, sex, wound type, depth, site, etiology, and exudate pH were collected. Wound pH was measured to determine if it could be a possible early indicator of infection, and bacterial wound cultures were performed as a control.
RESULTS: Analysis revealed that the biomarker had no cytotoxicity and caused no erythema, edema, or other adverse response. The rapid diagnostic biomarker demonstrated overall clinical sensitivity, specificity, accuracy, positive predictive value, and negative predictive value: 96.84%, 97.5%, 96.96%, 99.35%, and 88.63%, respectively. Moreover, infected wounds had higher pH values according to culture results and nearly 80% of chronic, nonhealing wounds were infected.
CONCLUSIONS: This biomarker enables caregivers to detect wound infection in a timely manner and treat it efficiently. Wound pH monitoring may potentially be a useful method for indicating the presence or absence of infection.