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NCT Number: NCT07562269

Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds

This study evaluates whether a digital decision support tool, called WoundPilot, can help primary care nurses make more accurate and consistent decisions when caring for patients with chronic wounds.

In daily practice, treatment decisions for chronic wounds can vary between clinicians, even when they assess the same patient. This variation may lead to delays in appropriate care, inconsistent treatment choices, or unnecessary referrals. WoundPilot was developed to guide clinicians through a structured wound assessment and link this assessment to clear treatment recommendations.

In this study, primary care nurses will assess a series of clinical cases either with or without the support of WoundPilot. Their decisions will be compared with an expert reference standard to determine whether the use of WoundPilot improves the accuracy of decisions and reduces differences between nurses.

The results of this study will help determine whether WoundPilot can support more consistent and evidence-based wound care in clinical practice.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location contact

Dimitri Beeckman, PhD

SUB_INVESTIGATOR

Hilde Beele, PhD

CONTACT

[email protected]

+3293323381

Hilde Beele, PhD

PRINCIPAL_INVESTIGATOR

Steven Smet, Master

CONTACT

[email protected]

+3293328793

Steven Smet, Master

SUB_INVESTIGATOR

About this study

Background Clinical decision-making in chronic wound care shows considerable variability, even when clinicians are presented with similar patient information. This variability may result in delayed or inappropriate treatment, inconsistent use of therapies, or failure to escalate care when clinically indicated.

Structured clinical decision support systems (CDSS) aim to reduce unwarranted variation by guiding clinicians through predefined assessment steps and linking these to management pathways. WoundPilot is an evidence-informed CDSS developed to support structured wound assessment and treatment decision-making in primary care.

Objective The primary objective is to evaluate the effect of WoundPilot on the accuracy and consistency of clinical decision-making in chronic wound care among primary care nurses.

Secondary objectives are to:

  • Assess alignment of wound assessment decisions with an expert reference standard
  • Evaluate whether WoundPilot reduces variability between nurses
  • Assess whether nurses better recognize and translate clinical changes
  • Evaluate usability of WoundPilot using the Dutch System Usability Scale (D-SUS)

Study Design

This study is a randomized parallel vignette study conducted among primary care nurses. Participants are randomly assigned to:

  • Intervention group: assessment of clinical cases using WoundPilot
  • Control group: assessment based on usual clinical reasoning without decision support Each participant evaluates a set of standardized clinical cases representing patients with chronic wounds.

Methods Participants include primary care nurses involved in wound care decision-making in home care or nursing home settings.

In the intervention group, participants receive a short training on WoundPilot and use the tool to assess clinical cases. In the control group, participants assess the same type of cases using their usual reasoning and verbalize their decision-making process.

For each case, participants make decisions regarding wound assessment and treatment planning, including supportive therapy, antimicrobial use, debridement, dressing selection, and referral.

An expert reference standard is established by a panel of wound care experts. Participant decisions are compared to this reference.

Outcomes

The primary outcome is the correctness of treatment decisions compared with the expert reference standard. Secondary outcomes include:

  • Correctness of wound assessment decisions
  • Between-nurse variability in decisions
  • Recognition and interpretation of clinical change
  • Usability of WoundPilot (Dutch System Usability Scale) Agreement with the expert reference and between participants will be quantified using appropriate statistical methods, including kappa statistics and mixed-effects models.

Significance This study evaluates whether a structured clinical decision support system can improve the accuracy and consistency of clinical decision-making in chronic wound care. Findings may inform the role of digital decision support tools in supporting evidence-based practice in primary care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary care nurses involved in wound care decision-making
  • Nurses working in home care or nursing home settings
  • Nurses who assess and/or adapt wound management in clinical practice
  • Nurses with a qualification corresponding to European Qualification Framework (EQF) level 5 or 6
  • Willing and able to provide informed consent

Exclusion criteria

  • Nurses not involved in wound care decision-making
  • Nurses not working in a primary care setting
  • Inability to understand the study procedures or complete the assessment tasks
  • Refusal or inability to provide informed consent

Treatment and study plan

WoundPilot

Device

WoundPilot is a software-based clinical decision support system (CDSS) designed to support structured wound assessment and treatment decision-making in primary care.

The system guides users through a stepwise assessment process using predefined decision nodes, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the entered information, WoundPilot provides structured guidance to support treatment planning, including recommendations on supportive therapy, local wound management, and referral.

The system incorporates evidence-informed clinical pathways and aims to standardize wound assessment and reduce variability in clinical decision-making.

Primary outcomes

  1. Accuracy of Treatment Decisions Compared With an Expert Reference Standard

    Time frame: During a single assessment session (approximately 2 hours)

    Accuracy of treatment decisions will be assessed by comparing each participant's treatment decisions for standardized chronic wound cases with an expert reference standard. Treatment decisions include supportive therapy, antimicrobial therapy, wound cleansing, debridement, choice of wound product, management of wound edges or wound environment, protection of exposed bone or tendon when applicable, referral or contact with another healthcare professional or department, wound swab, and additional technical investigations. Accuracy will be analyzed at the level of individual treatment decision components and as a composite correctness score per case.

Secondary outcomes

  1. Alignment of Wound Assessment Decisions With Expert Reference Standard

    Time frame: During a single assessment session (approximately 2 hours)

    Accuracy of wound assessment decisions will be evaluated by comparing participant assessments with an expert reference standard. This includes classification of wound type, assessment of infection (local, spreading, or systemic), evaluation of wound evolution, wound bed characteristics, presence of hypergranulation or exposed structures, amount of exudate, and assessment of wound edges and surrounding skin.

  2. Between-Nurse Variability in Treatment Decisions

    Time frame: During a single assessment session (approximately 2 hours)

    Variability in treatment decisions between participants will be assessed within each study group. Agreement between participants will be quantified using statistical measures such as Fleiss' kappa to evaluate consistency of treatment decisions across standardized cases.

  3. Between-Nurse Variability in Wound Assessment Decisions

    Time frame: During a single assessment session (approximately 2 hours)

    Variability in wound assessment decisions between participants will be evaluated within each study group. Agreement will be quantified using appropriate statistical methods (e.g., Fleiss' kappa) to assess consistency in the evaluation of decision-critical wound parameters.

  4. Recognition and Interpretation of Clinical Change

    Time frame: During a single assessment session (approximately 2 hours)

    Participants' ability to recognize and correctly interpret clinical changes over time will be assessed by comparing decisions between initial and follow-up case scenarios. Correct identification of wound evolution and appropriate adaptation of treatment decisions will be evaluated against the expert reference standard.

  5. Usability of WoundPilot (Dutch System Usability Scale)

    Time frame: During a single assessment session (approximately 2 hours)

    Usability of WoundPilot will be assessed using the Dutch System Usability Scale (D-SUS), a validated 10-item questionnaire scored on a 5-point Likert scale. The D-SUS provides a total score ranging from 0 to 100, with higher scores indicating better usability.

Study contacts

Contact information is provided by the study sponsor or research team.

Hilde Beele, PhD

CONTACT

[email protected]

+32 9 332 33 81

Steven Smet, Master

CONTACT

[email protected]

+3293328793

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Evaluation of the Effect of WoundPilot on the Accuracy and Consistency of Clinical Decision-Making in Chronic Wound Care: A Randomized Parallel Vignette Study Among Primary Care Nurses

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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