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REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Optimising wound monitoring: Can digital tools improve healing outcomes and clinic efficiency

Abstract

Background

Chronic wounds present significant challenges for patients and nursing care teams worldwide. Digital health tools offer potential for more standardised and efficient nursing care pathways but require further rigorous evaluation.

Objective

This retrospective matched cohort study aimed to compare the impacts of a digital tracking application for wound documentation versus traditional manual nursing assessments.

Methods

Data from 5236 patients with various wound types were analysed. Propensity score matching balanced groups, and bivariate tests, correlation analyses, linear regression, and Hayes' Process Macro Model 15 were utilised for a mediation-moderation model.

Results

Digital wound tracking was associated with significantly shorter healing durations (15 vs. 35 days) and fewer clinic nursing visits (3 vs. 5.8 visits) compared to standard nursing monitoring. Digital tracking demonstrated improved wound size reduction over time. Laboratory values tested did not consistently predict healing outcomes. Digital tracking exhibited moderate negative correlations with the total number of nursing visits. Regression analysis identified wound complexity, hospitalizations, and initial wound size as clinical predictors for more nursing visits in patients with diabetes mellitus (p < .01). Digital tracking significantly reduced the number of associated nursing visits for patients with peripheral vascular disease.

Conclusion

These findings suggest that digital wound management may streamline nursing care and provide advantages, particularly for comorbid populations facing treatment burdens.

Reporting Method

This study adhered to STROBE guidelines in reporting this observational research.

Relevance to Clinical Practice

By streamlining documentation and potentially shortening healing times, digital wound tracking could help optimise nursing resources, enhance wound care standards, and improve patient experiences. This supports further exploration of digital health innovations to advance evidence-based nursing practice.

Patient or public contribution

This study involved retrospective analysis of existing patient records and did not directly include patients or the public in the design, conduct, or reporting of the research.

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