Clinical trial NCT02704897: Tracking Wound Infection With Smartphone Technology
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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 492
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Significant visual impairment

Primary outcomes:
measure: Time from surgery to treatment for surgical site infection
timeFrame: Outcome assessed at 30 day follow-up
Secondary outcomes:
measure: Service Usage
timeFrame: Assessed at 30 day follow-up
measure: Access to Services
timeFrame: Assessed at 30 day follow-up
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary Edinburgh
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
affiliation: University of Edinburgh
name: Ewen Harrison, BM CHB
role: PRINCIPAL_INVESTIGATOR
References:
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.