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

Surgical Site Infection Clinical Trial

— INROADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069103
• Other study ID #: AC21032
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: July 2022

Study information

• Verified date: June 2021
• Source: University of Edinburgh
• Contact: Ewen M Harrison, MBChB, PhD
• Phone: 01312423614
• Email: ewen.harrison[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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".

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. We have previously developed a unique remote wound surveillance tool in a University of Edinburgh research setting. We 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Western General Hospital	Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	ISLACARE LTD (12108076), Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technology acceptance	Technology Intervention acceptance as measured by Telehealth Usability Questionnaire (TUQ)	30 days
Secondary	Health service usage	Attendance at community (general practice) or emergency hospital services (emergency department or the surgical treatment centre)	30 days
Secondary	Time-to-diagnosis (days) of surgical-site infection	Time-to-diagnosis (days) of surgical-site infection (CDC criteria)	30 days
Secondary	surgical-site infection interventions	Therapeutic intervention received for surgical site infection	30 days