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WithdrawnNCT02055599Updated Apr 26, 2023

WEMR With Clinical Decision Support for All Wounds

An observational study in Chronic Wounds, sponsored by Winthrop University Hospital. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by Winthrop University Hospital · Observational

Why this study was withdrawn
PI departure.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Wounds

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Keywords

  • Wound
  • Wound Healing
  • Pressure Ulcers
  • Chronic Wounds
  • Clinical Decision Support
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
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).

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

Exclusion Criteria:

  • Patients with Diabetic Foot Ulcers
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. To answer questions relevant to wound healing.

    * 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?

    Time frame: up to 6 months

Secondary outcomes

  1. Develop new parameters for clinical decision support based on wound data collected.

    Time frame: up to 6 months

06

Study locations

1 site
  • Winthrop University Hospital
    Mineola, New York 11501, United States
07

Registry details

Key details

Study ID
NCT02055599
Lead sponsor
Winthrop University Hospital
Responsible party
Sponsor
First posted
Feb 5, 2014
Start date
Apr 2013
Primary completion
Apr 1, 2018
Completion
Apr 1, 2018
Last update
Apr 26, 2023

Study contacts

Harold Brem, MD
principal investigator · Winthrop University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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