ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic (INROADE)

This is a implementation research study of a surgical wound tele-monitoring online tool developed at the University of Edinburgh and demonstrated in the "Tracking wound infection with smartphone technology" (TWIST) randomised control trial (NCT02704897) conducted in NHS Lothian. The study design is based on the Medical Research Council (MRC) "Guidance for developing and evaluating complex interventions".

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Device: Intervention

Detailed Description

Surgical site infection (SSI) is one of the most common complications following surgery with significant costs to patients and health systems. Earlier diagnosis and treatment of SSI can reduce its impact. The investigators have previously developed a unique remote wound surveillance tool in a University of Edinburgh research setting. The investigators have demonstrated in a previous randomised controlled trial (NCT02704897), that wound infection can be diagnosed sooner (in the first 7 days postoperatively) when this tool is used.

This 12-month implementation research study will be conducted across the general surgical departments of the Royal Infirmary of Edinburgh and the Western General Hospital (two large tertiary hospitals). Informed consent will be required from all patients prior to enrolment, with a target of 200 patients recruited.

All data during the study will be collected via online forms hosted on the ISLA care platform, self-submitted by patients based on their own concerns with their wound or prompted by a routine request to complete. These forms are based on the smartphone-delivered wound assessment model developed and delivered in the TWIST trial (based on the Center for Disease Control and Prevention (CDC) classification criteria, and the ASEPSIS model (Additional treatment, Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of Inpatient Stay)). Participants will be asked to upload at least one photograph of their wound each time they use the smartphone-delivered wound assessment tool. Participants will be sent one (1) reminder notification the following day if they have not completed a requested response.

On postoperative day 30-day, patients will be requested to complete an online questionnaire based on two validated questionnaires: Bluebelle Wound Healing Questionnaire (WHQ) and Telehealth Usability Questionnaire. Furthermore, a subset of patients will be asked to indicate their interest to take part in a separate semi-structured interview regarding their experience within the study, and views of telemedicine in routine postoperative care (target 20 patients).

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults (age ≥ 16 years) with the capacity to provide informed consent
• Patient undergoing abdominal surgery who own a smartphone capable of accessing and completing the online response form

Exclusion Criteria:

• Any participants with self-reported impairment that would prevent use of the online questionnaires (and no alternative means for completion e.g. assistance from family or carers).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Similar to the original TWIST trial, patients will receive access to the online tool hosted on the ISLA platform until postoperative day 30 which is composed of two parts: A series of simple questions related to the detection of surgical wound infection (e.g. redness, swelling, fluid leakage, etc). These questions would be expected to be routinely asked during in-person assessment, and these questions have been previously developed and tested within the TWIST trial (the only change being the addition of questions specifically relating to the change in these symptoms).; At least one image of their surgical wound(s). Patients will receive automated requests via notifications asking to complete the online tool over the 30-day period (every 3 days +/- 1 day), however they may also complete the online form whenever wished.

Device: Intervention; Similar to the original TWIST trial , patients will receive access to the online tool hosted on the ISLA platform until postoperative day 30 which is composed of two parts: A series of simple questions related to the detection of surgical wound infection (e.g. redness, swelling, fluid leakage, etc). These questions would be expected to be routinely asked during in-person assessment, and these questions have been previously developed and tested within the TWIST trial (the only change being the addition of questions specifically relating to the change in these symptoms).; At least one image of their surgical wound(s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technology acceptance	Technology Intervention acceptance as measured by Telehealth Usability Questionnaire (TUQ)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health service usage	Attendance at community (general practice) or emergency hospital services (emergency department or the surgical treatment centre)	30 days
Time-to-diagnosis (days) of surgical-site infection	Time-to-diagnosis (days) of surgical-site infection (CDC criteria)	30 days
surgical-site infection interventions	Therapeutic intervention received for surgical site infection	30 days

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: Medical Research Council; ISLACARE LTD (12108076)

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Implementation
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Postoperative Complications; Wounds and Injuries; Wound Infection; COVID-19; Surgical Wound; Surgical Wound Infection
• Other Study ID Numbers: AC21032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonomysed IPD shared for research purposes
• IPD Sharing Time Frame: One year following publication
• IPD Sharing Access Criteria: Request from chief investigator (Professor Ewen Harrison)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No