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Tracking Wound Infection With Smartphone Technology (TWIST)

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ClinicalTrials.gov Identifier: NCT02704897
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ewen Harrison, University of Edinburgh

Brief Summary:
This study aims to evaluate if a smartphone-delivered tool can help assess for wound infections, and if this improves access to care and results in earlier treatment. Participants will be randomised to one of two groups. The intervention group will receive the smartphone-delivered wound assessment tool (SWAT), to access if they have concerns about their wound. The trial period is 30 days.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Other: Wound Assessment Tool Not Applicable

Detailed Description:

Surgical site infection (SSI) is defined by the Centre for Disease Control and Prevention (CDC) as an infection in the skin and soft tissues of a surgical wound, within 30 days of the operation. It is a common problem, and complicates 2-10% of general surgery operations. The majority of cases are diagnosed outside of hospital and can be treated with oral antibiotics.

Interest in the use of technology in medicine is increasing, with the potential that more advanced technology will help facilitate communication between clinicians and patients, aid in the assessment of patients, and improve clinical decision making. Over two-thirds of people now own smartphones, and regularly use them to access the internet. The investigators wish to use a smartphone delivered questionnaire to help assess SSI and see if this improves access to care and time to treatment.

The investigators will be recruiting emergency surgery patients with smartphones at the Royal Infirmary and Western General Hospitals in Edinburgh.

Participants will be divided into two groups. One group will receive the wound assessment tool, if they are concerned about their wound, they can use the tool to answer a series of questions. If their answers suggest SSI, a clinician will contact them to advise further assessment and treatment. The participants will also be asked to respond to the tool three times during the trial (to collect responses from those without symptoms), and upload photos of their wounds to a secure database.

The second group of participants will receive normal post-operative care.

After 30 days, participants will have a follow-up consultation, to determine if they have had a wound infection (this can be via telephone or face-to-face, according to participant preference). They will also answer questions about their experience of the study, and use of services.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Can a Smartphone-delivered Tool Facilitate the Assessment of Surgical Site Infection, and Result in Earlier Treatment? A Randomized-controlled Trial in Emergency Surgery Patients.
Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm

Wound assessment tool - delivered via a smartphone. A link will be sent to participants on discharge, which can be accessed at any point should they have concerns about their wound.

They will also be sent the tool at 3 additional time-points.

Other: Wound Assessment Tool
A set of questions relating to the symptoms of wound infection

No Intervention: Control Arm
Normal Post-operative Care



Primary Outcome Measures :
  1. Time from surgery to treatment for surgical site infection [ Time Frame: Outcome assessed at 30 day follow-up ]
    Measured in days from surgery to commencing antibiotic treatment


Secondary Outcome Measures :
  1. Service Usage [ Time Frame: Assessed at 30 day follow-up ]
    Number of attendances at General Practice (GP) and Accident and Emergency (A&E).

  2. Access to Services [ Time Frame: Assessed at 30 day follow-up ]
    How long in days between experiencing first symptom and being reviewed by A&E, GP or surgical team



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Emergency Abdominal Surgery Patients
  • Smartphone Owners
  • Able to give valid consent

Exclusion Criteria:

  • Significant visual impairment

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): NCT02704897


Contacts
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Contact: Ewen Harrison, BM CHB 0131 242 3616 ewen.harrison@ed.ac.uk

Locations
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United Kingdom
Royal Infirmary Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Ewen M Harrison, BMBCH    0131 242 3616    ewen.harrison@ed.ac.uk   
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Mark Potter, MBCHB       mark.potter@nhslothian.scot.nhs.uk   
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Ewen Harrison, BM CHB University of Edinburgh

Additional Information:
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Responsible Party: Ewen Harrison, Senior Lecturer, Consultant Hepatobiliary and Transplant Surgeon, University of Edinburgh
ClinicalTrials.gov Identifier: NCT02704897     History of Changes
Other Study ID Numbers: AC16032
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes