Clinical Decision Support Tool for Wounds

Recruiting at 5 trial locations

Overseen By Seth Schobel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must not be taking: Immunosuppressants

Disqualifiers: Diabetes, Vascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 48-72 hours per debridement cycle, ongoing for up to 1 year

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital. The WounDx device is experimental and not yet approved by the United States Food and Drug Administration (FDA). WounDx uses information about a patient's wound to generate a report that a surgeon may use to help determine when to close or not close the wound. The final decision to close the wound remains with the surgeon. The results from this pilot trial will inform a larger pivotal trial.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the WounDx™ Clinical Decision Support Tool treatment?

The research highlights the importance of patient-reported outcomes and validated assessment tools in evaluating the benefits of wound treatments. These tools, like the Pressure Ulcer Scale for Healing, help track healing progress and patient satisfaction, which can indirectly support the effectiveness of clinical decision support tools like WounDx™. ^{1 2 3 4 5}

Is the WounDx™ Clinical Decision Support Tool safe for use in humans?

The research does not provide specific safety data for the WounDx™ Clinical Decision Support Tool or similar tools for wound management, but it highlights that clinical decision support systems can reduce medical errors if designed properly. ^{6 7 8 9 10}

How is the WounDx™ Clinical Decision Support Tool treatment different from other wound treatments?

The WounDx™ Clinical Decision Support Tool is unique because it uses a decision-making system to help healthcare providers choose the best materials and strategies for treating chronic wounds, improving care quality by simplifying complex decisions. ^{4 7 10 11 12}

Research Team

Eric Elster, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Eligibility Criteria

This trial is for individuals with large wounds (≥75cm2) from injuries like amputations or open fractures, specifically on extremities including shoulders and buttocks. The wound must be suitable for Negative Pressure Wound Therapy without gel packs.

Inclusion Criteria

My wound can be treated with a specific vacuum-assisted closure device.

My wound is larger than 75 square centimeters.

I have an injury to my arm, leg, shoulder, or buttock without internal organ involvement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care with or without the WounDx™ report to aid in determining wound readiness for closure

48-72 hours per debridement cycle, ongoing for up to 1 year

Regular visits for debridement every 2-3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• WounDx™ Clinical Decision Support Tool

Trial Overview The study tests the WounDx device, which isn't FDA-approved yet. It provides reports to help surgeons decide when to close a wound. Participants will receive standard care; some will also use the WounDx tool.

Participant Groups

Group I: WounDx Experimental Treatment 1 Intervention

This is the intervention group that receives standard of care plus the WounDx™ report to augment the clinicians' judgment regarding the wounds readiness to close.

Group II: Standard of Care Active Control 1 Intervention

This is the control group that receives the standard of care of serial wound irrigation, Negative Pressure Wound Therapy, and surgical debridement with the attending clinician determining if a wound is ready to close.

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Grady Memorial Hospital

Collaborator

Trials

5

Recruited

8,500+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Findings from Research

Clinical decision support systems, like Project IMPACT and APACHE III, are essential for managing patient outcomes in critical care by enabling data analysis and predictive modeling.

These tools help clinicians compare actual patient outcomes with predicted outcomes, which can improve quality control and process improvement in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support systems for outcome measurement and management. Sakallaris, BR., Jastremski, CA., Von Rueden, KT.[2019]

A study analyzing the usability of clinical decision support systems (CDSS) for community-acquired pneumonia and neutropenic fever found 422 recorded events, including 3 mistakes that could have been life-threatening, highlighting the critical need for careful design and evaluation of these systems.

Incorporating usability engineering principles early in the design of CDSS can help identify interface issues that may lead to adverse medical events, emphasizing the importance of user-friendly software in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How usability of a web-based clinical decision support system has the potential to contribute to adverse medical events. Graham, TA., Kushniruk, AW., Bullard, MJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures for chronic wounds with particular reference to pressure ulcer research: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Benefit evaluation in the therapy of chronic wounds from the patients' perspective--development and validation of a new method. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The Toronto Symptom Assessment System for Wounds: a new clinical and research tool. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Utilizing Precision Medicine to Estimate Timing for Surgical Closure of Traumatic Extremity Wounds. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Implementing the push tool in clinical practice: revisions and results. [2005]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical decision support systems for outcome measurement and management. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Using wound care algorithms: a content validation study. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Development and evaluation of data entry templates based on the entity-attribute-value model for clinical decision support of pressure ulcer wound management. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

How usability of a web-based clinical decision support system has the potential to contribute to adverse medical events. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a Knowledge Base for Chronic Wound Management Using the Decision Model & Notation. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Health professionals' decision-making in wound management: a grounded theory. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Impact of a decision tree on chronic wound care. [2018]