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WEMR With Clinical Decision Support for All Wounds

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ClinicalTrials.gov Identifier: NCT02055599
Recruitment Status : Recruiting
First Posted : February 5, 2014
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Harold Brem, MD, Winthrop University Hospital

Brief Summary:

The goal of this project to begin using a wound research database with clinical decision support features at Winthrop University Hospital. A research database is an electronic computer system that is used to collect patient information. Clinical decision support is the ability for a computer system to provide medical assistance to the doctor through alerts and recommendations based on the information entered. The investigators believe that use of a wound clinical decision support tool, much like a drug, will improve healing in patients with chronic wounds (wounds that fail to heal over the course of weeks) and ultimately lower the risk of death and illness caused by these wounds. In order to develop a useful clinical decision support tool, investigators first need to develop a large research database to determine the data points important for wound healing. The investigators will be using the data collected in this study for future research and publication. Data will be reviewed to answer questions important to wound healing and for the purpose of developing the clinical decision support alert system.

After providing informed consent, participants will be asked a series of questions related to their past medical history, and relevant wound data will be collected. Study staff will photograph the wound at baseline, and once per week until the wound is completely healed, or for a duration of six months.

Participants will be expected to return to Winthrop University Hospital for wound follow-up on a regular basis, or as determined by the Principal Investigator.


Condition or disease
Chronic Wounds

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wound Research Database With Clinical Decision Support for Patients With All Wounds
Study Start Date : April 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To answer questions relevant to wound healing. [ Time Frame: up to 6 months ]
    • How does wound pathology relate to wound healing?
    • How do different types of bacterial infections affect wound healing?
    • To determine the etiology of morbidity, mortality and cost in chronic wound patients.
    • How does providing the patient with an individualized data summary and photos of their wound affect wound healing?


Secondary Outcome Measures :
  1. Develop new parameters for clinical decision support based on wound data collected. [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female patients at Winthrop University Hospital with any chronic wound (defined as a break in the integument).
Criteria

Inclusion Criteria:

  • 21 years or older
  • Diagnosed with a wound (defined as a break in the integument)
  • Must be willing and able to provide written informed consent

Exclusion Criteria:

  • Patients with Diabetic Foot Ulcers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055599


Contacts
Contact: Julie DiGregorio, CCRP (516) 663-9614 jdigregorio@winthrop.org

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Julie DiGregorio, CCRP    516-663-9614    jdigregorio@winthrop.org   
Principal Investigator: Harold Brem, MD         
Sub-Investigator: Scott Gorenstein, MD         
Sub-Investigator: Shayan Shirazian, MD         
Sub-Investigator: Julie DiGregorio, CCRP         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Harold Brem, MD Winthrop University Hospital

Responsible Party: Harold Brem, MD, Chief, Division of Wound Healing and Regenerative Medicine, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT02055599     History of Changes
Other Study ID Numbers: 13308-1
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Harold Brem, MD, Winthrop University Hospital:
Wound
Wound Healing
Pressure Ulcers
Chronic Wounds
Clinical Decision Support

Additional relevant MeSH terms:
Wounds and Injuries