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Tracking Wound Infection With Smartphone Technology (TWIST)

11. februar 2019 opdateret af: Ewen Harrison, University of Edinburgh

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.

Studieoversigt

Status

Ukendt

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

Interventionel

Tilmelding (Forventet)

500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant visual impairment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ewen Harrison, BM CHB, University of Edinburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2016

Primær færdiggørelse (Forventet)

1. juni 2019

Studieafslutning (Forventet)

1. juli 2019

Datoer for studieregistrering

Først indsendt

2. marts 2016

Først indsendt, der opfyldte QC-kriterier

4. marts 2016

Først opslået (Skøn)

10. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Infektion på det kirurgiske sted

Kliniske forsøg med Wound Assessment Tool

3
Abonner