- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Edinburgh, Verenigd Koninkrijk, EH4 2XU
- Werving
- Western General Hospital
-
Contact:
- Mark Potter, MBCHB
- E-mail: mark.potter@nhslothian.scot.nhs.uk
-
Edinburgh, Verenigd Koninkrijk, EH16 4SA
- Werving
- Royal Infirmary Edinburgh
-
Contact:
- Ewen M Harrison, BMBCH
- Telefoonnummer: 0131 242 3616
- E-mail: ewen.harrison@ed.ac.uk
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Emergency Abdominal Surgery Patients
- Smartphone Owners
- Able to give valid consent
Exclusion Criteria:
- Significant visual impairment
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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
|
Geen tussenkomst: Control Arm
Normal Post-operative Care
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Time from surgery to treatment for surgical site infection
Tijdsspanne: Outcome assessed at 30 day follow-up
|
Measured in days from surgery to commencing antibiotic treatment
|
Outcome assessed at 30 day follow-up
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Service Usage
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ewen Harrison, BM CHB, University of Edinburgh
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AC16032
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Wound Assessment Tool
-
National Institute of Allergy and Infectious Diseases...VoltooidVaginale infectieVerenigde Staten
-
Université de MontréalInstitut de Recherche Robert-Sauvé en Santé et en Sécurité du TravailOnbekend
-
Tolerion, Inc.Actief, niet wervendDiabetes mellitus, type 1Verenigde Staten
-
Tolerion, Inc.IngetrokkenDiabetes mellitus, type 1Verenigde Staten
-
Tolerion, Inc.IngetrokkenDiabetes mellitus, type 1
-
Vanderbilt University Medical CenterNational Institute of Mental Health (NIMH)WervingAutisme Spectrum StoornisVerenigde Staten
-
Laboratoires URGOOnbekend
-
Integra LifeSciences CorporationBeëindigdPilonidale ziekteVerenigde Staten
-
University of GlasgowScottish Universities Environmental Research CentreVoltooid
-
Vanderbilt University Medical CenterNational Institute of Mental Health (NIMH)WervingAutisme Spectrum StoornisVerenigde Staten