Tracking Wound Infection With Smartphone Technology (TWIST)
Primary Purpose
Surgical Site Infection
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Wound Assessment Tool
Sponsored by
About this trial
This is an interventional diagnostic trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria:
- Emergency Abdominal Surgery Patients
- Smartphone Owners
- Able to give valid consent
Exclusion Criteria:
- Significant visual impairment
Sites / Locations
- Royal Infirmary EdinburghRecruiting
- Western General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm
Arm Description
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.
Normal Post-operative Care
Outcomes
Primary Outcome Measures
Time from surgery to treatment for surgical site infection
Measured in days from surgery to commencing antibiotic treatment
Secondary Outcome Measures
Service Usage
Number of attendances at General Practice (GP) and Accident and Emergency (A&E).
Access to Services
How long in days between experiencing first symptom and being reviewed by A&E, GP or surgical team
Full Information
NCT ID
NCT02704897
First Posted
March 2, 2016
Last Updated
February 11, 2019
Sponsor
University of Edinburgh
1. Study Identification
Unique Protocol Identification Number
NCT02704897
Brief Title
Tracking Wound Infection With Smartphone Technology
Acronym
TWIST
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 Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Edinburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Normal Post-operative Care
Intervention Type
Other
Intervention Name(s)
Wound Assessment Tool
Intervention Description
A set of questions relating to the symptoms of wound infection
Primary Outcome Measure Information:
Title
Time from surgery to treatment for surgical site infection
Description
Measured in days from surgery to commencing antibiotic treatment
Time Frame
Outcome assessed at 30 day follow-up
Secondary Outcome Measure Information:
Title
Service Usage
Description
Number of attendances at General Practice (GP) and Accident and Emergency (A&E).
Time Frame
Assessed at 30 day follow-up
Title
Access to Services
Description
How long in days between experiencing first symptom and being reviewed by A&E, GP or surgical team
Time Frame
Assessed at 30 day follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Emergency Abdominal Surgery Patients
Smartphone Owners
Able to give valid consent
Exclusion Criteria:
Significant visual impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewen Harrison, BM CHB
Phone
0131 242 3616
Email
ewen.harrison@ed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewen Harrison, BM CHB
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewen M Harrison, BMBCH
Phone
0131 242 3616
Email
ewen.harrison@ed.ac.uk
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Potter, MBCHB
Email
mark.potter@nhslothian.scot.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31585971
Citation
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.
Results Reference
derived
Links:
URL
https://www.gov.uk/guidance/surgical-site-infection-surveillance-service-ssiss
Description
Public Health England. Surgical site infection surveillance service (SSISS). (2014).
URL
http://media.ofcom.org.uk/facts/
Description
OFCOM. Facts & figures. (2010).
URL
http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf
Description
CDC/OID/NCEZID/DHQP. 9 surgical site infection (SSI) event. (2016).
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Tracking Wound Infection With Smartphone Technology
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