Feasibility Trial for Postoperative Wound Surveillance Using Smartphones

NCT02735525 | Completed

• 1 other identifier: 2015-1581
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed trial is a pilot to test a smartphone application (app) that will ultimately allow patients to take and transmit photos of their postoperative wounds from home and relay other symptom information. This protocol covers the single-institution pilot study of the app's use in the period between hospital discharge and a patient's first follow-up clinic visit. The investigators will recruit vascular surgery patients either preoperatively in clinic or in the post-operative, pre-discharge period following surgery to participate in the pilot. Using a training protocol refined in the usability-testing phase of the project, patients will be trained to use the smartphone and the wound surveillance app prior to discharge. Patients will use the app from home to take send digital images of their postoperative wounds and answer a short survey, all of which will be transmitted to a secure database maintained by the University of Wisconsin (UW) Department of Surgery and accessible only to UW-employed study personnel. These data will be evaluated by one of three vascular surgery service nurse practitioners (NPs) daily and entered into the medical record. Patients who have concerning findings either in their images or in their survey answers will be contacted for further evaluation. Smartphones will be provided to patients who do not have one of their own, through a partnership with AT\&T. Sociodemographic and comorbidity data collected from the medical record will be kept at UW Department of Surgery on a secure server and accessible only to UW employed study personnel.

Conditions

Surgical Wound Infection

Keywords

telemedicine; smartphone

Outcome Measures

Primary Outcomes (1)

• Protocol completion

  The percentage of participants who completed the app for the full length of the protocol (from the day of discharge to the day of scheduled clinic follow-up) without requiring a reminder phone call.

  Assessed at 2 weeks from enrollment of each participant

Secondary Outcomes (5)

• Patient willingness to participate

  Assessed at consent/enrollment of eligible patients

• Participant satisfaction

  Assessed at 2 weeks from enrollment for each participant

• Wound complication detection

  Assessed daily through 2 weeks from enrollment for each participant

• Time needed to successfully complete the training module

  Assessed at enrollment for each participant

• Burden of protocol on clinical workflow

  Through study completion, an average of 6 months

Study Arms (1)

Smartphone monitoring

EXPERIMENTAL

Intervention arm

Device: Smartphone monitoring

Interventions

Smartphone monitoring DEVICE

Patients will be trained to use the smartphone and the wound surveillance app prior to discharge. Patients will use the app from home to take send digital images of their postoperative wounds and answer a short survey, all of which will be transmitted to a secure database maintained by the UW Department of Surgery and accessible only to UW-employed study personnel. These data will be evaluated by one of three vascular surgery service nurse practitioners (NPs) daily. Patients who have concerning findings either in their images or in their survey answers will be contacted for further evaluation.

Smartphone monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vascular surgery patient capable of independently completing protocol or who has an identifiable competent caregiver
• Incision \>3 cm in length

You may not qualify if:

• No decisional capacity and absence of competent caregiver
• Identifying mark in area of the wound that would be capture in digital image of the wound
• Under age 18 years

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Gunter RL, Fernandes-Taylor S, Rahman S, Awoyinka L, Bennett KM, Weber SM, Greenberg CC, Kent KC. Feasibility of an Image-Based Mobile Health Protocol for Postoperative Wound Monitoring. J Am Coll Surg. 2018 Mar;226(3):277-286. doi: 10.1016/j.jamcollsurg.2017.12.013. Epub 2018 Jan 19.

  PMID: 29366555 RESULT

• Fernandes-Taylor S, Gunter RL, Bennett KM, Awoyinka L, Rahman S, Greenberg CC, Kent KC. Feasibility of Implementing a Patient-Centered Postoperative Wound Monitoring Program Using Smartphone Images: A Pilot Protocol. JMIR Res Protoc. 2017 Feb 22;6(2):e26. doi: 10.2196/resprot.6819.

  PMID: 28228369 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth C Kent, MD

  University of Wisconsin, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 12, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)