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Wearable Devices for Early Detection of Postoperative Infection

A Systematic Review of Wearable Infection Detection Wristbands for Postoperative Patients: Evaluating the Efficacy of WBC and CRP Monitoring and AI-Assisted Early Detection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07334925
Acronym
Wearable Wrist
Enrollment
1284
Registered
2026-01-12
Start date
2025-07-01
Completion date
2025-10-27
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wearable Devices

Keywords

Wearable biosensors, postoperative infection, artificial intelligence

Brief summary

This systematic review aims to evaluate the efficacy, accuracy, and clinical applicability of wearable infection detection wristbands in postoperative patients across ophthalmology, orthopaedic surgery, and general surgery. The review focuses on devices capable of monitoring inflammatory biomarkers-particularly white blood cell (WBC) counts and C-reactive protein (CRP)-and examines the added value of artificial intelligence (AI) algorithms for early infection detection. The study synthesizes available evidence on clinical outcomes, predictive accuracy, usability, and feasibility of biosensor-based infection surveillance in postoperative care. It is expected to provide an evidence-based framework for integrating wearable biosensors into perioperative management protocols and to guide future multicenter clinical validation studies.

Detailed description

Postoperative infection remains one of the most common and serious complications following surgical procedures. Early detection of infection is critical for optimizing outcomes and reducing morbidity. Conventional laboratory monitoring using intermittent WBC and CRP testing is invasive and time-dependent, often delaying timely clinical intervention. Recent advances in wearable biosensor technology have enabled continuous, non-invasive monitoring of physiological and biochemical parameters. Several wearable platforms are now capable of detecting early inflammatory changes through electrochemical or optical sensing, with CRP being the most validated biomarker. Integration of AI algorithms further enhances predictive performance by analyzing complex data patterns and providing early alerts to clinicians. This systematic review adheres to PRISMA 2020 guidelines and aims to consolidate available clinical and experimental evidence on wearable biosensors capable of postoperative infection detection, emphasizing WBC and CRP monitoring wristbands and AI-assisted analysis. By synthesizing data from ophthalmology, orthopaedics, and general surgery, the review will assess diagnostic accuracy, clinical outcomes, and feasibility of these technologies in diverse healthcare contexts. The findings are expected to inform future research directions, highlight existing technological gaps, and propose recommendations for clinical implementation and regulatory validation.

Interventions

DIAGNOSTIC_TESTWhite Blood Cell (WBC)

Detected by wearable device

detected by wearable device

Sponsors

Benha University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults aged 18 years or older. Patients undergoing ophthalmologic, orthopedic, or general surgical procedures. Postoperative patients monitored using a wearable infection detection device or biosensor capable of continuous or intermittent assessment of inflammatory biomarkers, including: White blood cell (WBC) count and/or C-reactive protein (CRP) levels. Wearable devices may incorporate artificial intelligence or machine-learning algorithms for infection prediction. Patients receiving standard postoperative care, including conventional laboratory testing and/or clinical monitoring, for comparison. Ability to provide written informed consent.

Exclusion criteria

Patients aged \<18 years. Non-human studies (animal or in-vitro). Use of wearable devices that monitor only physiological parameters (e.g., temperature, heart rate, oxygen saturation) without inflammatory biomarker assessment (WBC or CRP). Patients who are hemodynamically unstable at the time of enrollment. Inability or unwillingness to provide informed consent. Duplicate enrollment or participation in another interventional study that may interfere with outcomes.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy of Wearable Devices for Detection of Postoperative Infection1 weekSensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of wearable devices for detecting postoperative infection, using standard clinical diagnosis as the reference standard.
Time to Postoperative Infection Detection Using Wearable Devices Compared With Standard Care1 weekTime interval between clinical onset of postoperative infection and detection by wearable devices compared with detection by standard postoperative care protocols.
Predictive Accuracy of AI-Integrated Wearable Monitoring for Early Postoperative Infection1 weekImprovement in early postoperative infection prediction accuracy achieved by AI-integrated wearable monitoring compared with traditional laboratory-based monitoring methods.

Secondary

MeasureTime frameDescription
Secondary outcomes1 weekPatient recovery metrics (readmission rate, wound healing time). Feasibility and usability of wearable devices in postoperative settings. Device validation quality and risk of bias across included studies.
Methodological Quality and Risk of Bias of Wearable Device Validation1 weekQuality of wearable device validation and risk of bias assessed using standardized evaluation tools appropriate for diagnostic accuracy studies.
Time to Wound Healing1 weekDuration from surgery to clinically confirmed wound healing based on standardized postoperative assessment criteria.
Feasibility and Usability of Wearable Devices in Postoperative Monitoring1 weekAssessment of feasibility and usability of wearable devices in the postoperative setting, including adherence rates, device-related issues, and patient-reported usability scores.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026