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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

Tracking Information
First Submitted Date  ICMJE March 2, 2016
First Posted Date  ICMJE March 10, 2016
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02704897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2016)
  • Service Usage [ Time Frame: Assessed at 30 day follow-up ]
    Number of attendances at General Practice (GP) and Accident and Emergency (A&E).
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tracking Wound Infection With Smartphone Technology
Official Title  ICMJE 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.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Surgical Site Infection
Intervention  ICMJE Other: Wound Assessment Tool
A set of questions relating to the symptoms of wound infection
Study Arms  ICMJE
  • 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.

    Intervention: Other: Wound Assessment Tool
  • No Intervention: Control Arm
    Normal Post-operative Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2019)
500
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2016)
400
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant visual impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ewen Harrison, BM CHB 0131 242 3616 ewen.harrison@ed.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02704897
Other Study ID Numbers  ICMJE AC16032
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ewen Harrison, University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ewen Harrison, BM CHB University of Edinburgh
PRS Account University of Edinburgh
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP