Tracking Wound Infection With Smartphone Technology (TWIST)

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.

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Other: Wound Assessment Tool

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: Interventional
• Enrollment (Actual): 492
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Significant visual impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from surgery to treatment for surgical site infection	Measured in days from surgery to commencing antibiotic treatment	Outcome assessed at 30 day follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Service Usage	Number of attendances at General Practice (GP) and Accident and Emergency (A&E).	Assessed at 30 day follow-up
Access to Services	How long in days between experiencing first symptom and being reviewed by A&E, GP or surgical team	Assessed at 30 day follow-up

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Ewen Harrison, BM CHB, University of Edinburgh

Publications and helpful links

General Publications

• McLean KA, Mountain KE, Shaw CA, Drake TM, Ots R, Knight SR, Fairfield CJ, Sgro A, Skipworth RJE, Wigmore SJ, Potter MA, Harrison EM. Can a smartphone-delivered tool facilitate the assessment of surgical site infection and result in earlier treatment? Tracking wound infection with smartphone technology (TWIST): protocol for a randomised controlled trial in emergency surgery patients. BMJ Open. 2019 Oct 3;9(10):e029620. doi: 10.1136/bmjopen-2019-029620.

Helpful Links

• Public Health England. Surgical site infection surveillance service (SSISS). (2014).
• CDC/OID/NCEZID/DHQP. 9 surgical site infection (SSI) event. (2016).

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2016
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimated): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: AC16032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO