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Completed

NCT Number: NCT02704897

Tracking Wound Infection With Smartphone Technology

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary Edinburgh, Edinburgh, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Significant visual impairment

Treatment and study plan

Wound Assessment Tool

Other

A set of questions relating to the symptoms of wound infection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study 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.

Acronym: TWIST

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2016
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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