Tracking Wound Infection With Smartphone Technology

NCT ID: NCT02704897

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-14

Study Completion Date

2020-11-20

Brief Summary

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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

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Wound Assessment Tool

Intervention Type OTHER

A set of questions relating to the symptoms of wound infection

Control Arm

Normal Post-operative Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wound Assessment Tool

A set of questions relating to the symptoms of wound infection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Significant visual impairment
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ewen Harrison, BM CHB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Royal Infirmary Edinburgh

Edinburgh, , United Kingdom

Site Status

Western General Hospital

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31585971 (View on PubMed)

Related Links

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https://www.gov.uk/guidance/surgical-site-infection-surveillance-service-ssiss

Public Health England. Surgical site infection surveillance service (SSISS). (2014).

http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf

CDC/OID/NCEZID/DHQP. 9 surgical site infection (SSI) event. (2016).

Other Identifiers

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AC16032

Identifier Type: -

Identifier Source: org_study_id

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