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

NCT05069103 | Completed

• 1 other identifier: AC21032
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 2

Brief 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".

Conditions

Surgical Site Infection

Keywords

Telemedicine; Implementation

Outcome Measures

Primary Outcomes (1)

• Technology acceptance

  Technology Intervention acceptance as measured by Telehealth Usability Questionnaire (TUQ)

  30 days

Secondary Outcomes (3)

• Health service usage

  30 days

• Time-to-diagnosis (days) of surgical-site infection

  30 days

• surgical-site infection interventions

  30 days

Study Arms (1)

Intervention

EXPERIMENTAL

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: 1. 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). 2. 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

Interventions

Intervention DEVICE

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: 1. 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). 2. At least one image of their surgical wound(s).

Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Edinburgh: lead
• Medical Research Council: collaborator
• ISLACARE LTD (12108076): collaborator

Study Sites (2)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (2)

• McLean KA, Sgro A, Brown LR, Buijs LF, Mozolowski K, Daines L, Cresswell K, Potter MA, Bouamrane MM, Harrison EM. Implementation of digital remote postoperative monitoring in routine practice: a qualitative study of barriers and facilitators. BMC Med Inform Decis Mak. 2024 Oct 21;24(1):307. doi: 10.1186/s12911-024-02670-5.

  PMID: 39434121 DERIVED

• McLean KA, Sgro A, Brown LR, Buijs LF, Daines L, Potter MA, Bouamrane MM, Harrison EM. Evaluation of remote digital postoperative wound monitoring in routine surgical practice. NPJ Digit Med. 2023 May 5;6(1):85. doi: 10.1038/s41746-023-00824-9.

  PMID: 37147462 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Methods

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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: 1. 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). 2. 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.

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 6, 2021
• Study Start: July 5, 2021
• Primary Completion: June 1, 2022
• Study Completion: May 5, 2023
• Last Updated: June 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: One year following publication
• Access Criteria: Request from chief investigator (Professor Ewen Harrison)

Locations

GB (2)