- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02704897
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ewen Harrison, BM CHB
- Telefonnummer: 0131 242 3616
- E-mail: ewen.harrison@ed.ac.uk
Studiesteder
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Edinburgh, Det Forenede Kongerige, EH4 2XU
- Rekruttering
- Western General Hospital
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Kontakt:
- Mark Potter, MBCHB
- E-mail: mark.potter@nhslothian.scot.nhs.uk
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Edinburgh, Det Forenede Kongerige, EH16 4SA
- Rekruttering
- Royal Infirmary Edinburgh
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Kontakt:
- Ewen M Harrison, BMBCH
- Telefonnummer: 0131 242 3616
- E-mail: ewen.harrison@ed.ac.uk
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Emergency Abdominal Surgery Patients
- Smartphone Owners
- Able to give valid consent
Exclusion Criteria:
- Significant visual impairment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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. |
A set of questions relating to the symptoms of wound infection
|
Ingen indgriben: Control Arm
Normal Post-operative Care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time from surgery to treatment for surgical site infection
Tidsramme: Outcome assessed at 30 day follow-up
|
Measured in days from surgery to commencing antibiotic treatment
|
Outcome assessed at 30 day follow-up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Service Usage
Tidsramme: Assessed at 30 day follow-up
|
Number of attendances at General Practice (GP) and Accident and Emergency (A&E).
|
Assessed at 30 day follow-up
|
Access to Services
Tidsramme: Assessed at 30 day follow-up
|
How long in days between experiencing first symptom and being reviewed by A&E, GP or surgical team
|
Assessed at 30 day follow-up
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ewen Harrison, BM CHB, University of Edinburgh
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AC16032
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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