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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02704897
Other study ID # AC16032
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2016
Est. completion date November 20, 2020

Study information

Verified date May 2024
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 492
Est. completion date November 20, 2020
Est. primary completion date October 20, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Emergency Abdominal Surgery Patients - Smartphone Owners - Able to give valid consent Exclusion Criteria: - Significant visual impairment

Study Design


Intervention

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

Locations

Country Name City State
United Kingdom Royal Infirmary Edinburgh Edinburgh
United Kingdom Western General Hospital Edinburgh

Sponsors (1)

Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Service Usage Number of attendances at General Practice (GP) and Accident and Emergency (A&E). Assessed at 30 day follow-up
Secondary 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
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