Smart Wound Dressings and Biosensors in Wound Management: A Systematic Review of Clinical Effectiveness and Diagnostic/Monitoring Performance

Smart dressings integrating sensors (pH, temperature, moisture, oxygen, infection biomarkers) promise earlier detection of infection and non-healing. However, strong analytical performance of a sensor does not demonstrate diagnostic accuracy or patient benefit. This review will map the evidence along four levels: analytical validation, diagnostic validation, clinical validation, and clinical impact.Objectives Primary objective: To evaluate, in human studies, the clinical impact of smart dressings/biosensor-integrated wound monitoring systems (healing, infection, complications) compared with standard care or conventional dressings. Secondary objectives: 1. Diagnostic accuracy for infection detection against a reference standard. 2. Ability to measure relevant wound biomarkers and detect early biological change. 3. Safety, tolerability and biocompatibility. 4. Clinical feasibility and continuous/remote monitoring capability. 5. Economic outcomes. 6. Technological barriers to clinical adoption. 4. Eligibility criteria (PICO/PECO) Population Humans with acute or chronic wounds: diabetic foot ulcers, venous/arterial ulcers, pressure injuries, surgical/postoperative wounds, burns, traumatic wounds, infected wounds. Intervention / index test Dressings or dressing-based systems that detect, measure, transmit or signal wound-relevant biological/physiological information (electrochemical, optical, colorimetric, pH, temperature, moisture, oxygen, biomarker, bacterial/infection sensors; wireless/connected or real-time monitoring systems). Comparator Conventional dressing/standard care; no sensor; another smart device; reference standard (e.g., clinical diagnosis, wound culture, laboratory assay); none (single-arm technological/diagnostic studies). Study designs included RCTs, non-randomized interventional studies, prospective/retrospective cohorts, diagnostic accuracy studies, clinical validation and feasibility studies reporting relevant data. Study designs excluded Narrative reviews, editorials, commentaries, letters without original data, conference abstracts without sufficient data, purely theoretical papers, studies without wounds, studies of conventional dressings only, studies with non-extractable results. Animal and in vitro studies Will not be pooled with human data. They will be identified, mapped and reported in a separate descriptive section. Time frame Published from 1 January 2020 to the date of the final search, which will be reported in the manuscript and in the PRISMA-S supplementary material. Pre-2020 work is used for context only. Language No language restrictions will be applied. Non-English/non-French articles will be translated using a machine translation tool (e.g., DeepL, Google Translate), with verification of key data by a fluent speaker where available. Outcomes • Clinical: complete healing, wound area reduction, time to healing, infection, early infection detection, complications, readmission, surgery, quality of life, pain, number of dressing changes, length of stay. • Diagnostic/analytical: sensitivity, specificity, PPV, NPV, accuracy, AUC, agreement with reference method, limit of detection, precision, reproducibility, signal stability. • Technological: response time, continuous vs intermittent monitoring, wireless transmission, battery life, biocompatibility, safety, usability, skin tolerance. • Economic: costs, cost-effectiveness, consultations, hospitalizations, dressing changes.