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

Primary Purpose

Surgical Site Infection

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Surgical Site Infection focused on measuring Telemedicine, Implementation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Royal Infirmary of EdinburghRecruiting
  • Western General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2021
Last Updated
October 5, 2021
Sponsor
University of Edinburgh
Collaborators
Medical Research Council, ISLACARE LTD (12108076)
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1. Study Identification

Unique Protocol Identification Number
NCT05069103
Brief Title
ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic
Acronym
INROADE
Official Title
ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
Medical Research Council, ISLACARE LTD (12108076)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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".
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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Telemedicine, Implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Technology acceptance
Description
Technology Intervention acceptance as measured by Telehealth Usability Questionnaire (TUQ)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Health service usage
Description
Attendance at community (general practice) or emergency hospital services (emergency department or the surgical treatment centre)
Time Frame
30 days
Title
Time-to-diagnosis (days) of surgical-site infection
Description
Time-to-diagnosis (days) of surgical-site infection (CDC criteria)
Time Frame
30 days
Title
surgical-site infection interventions
Description
Therapeutic intervention received for surgical site infection
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewen M Harrison, MBChB, PhD
Phone
01312423614
Email
ewen.harrison@ed.ac.uk
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewen M Harrison, MBChB, PhD
Phone
0131 242 3614
Email
ewen.harrison@ed.ac.uk
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark A Potter, MBChB
Phone
0131 242 3614
Email
mark.potter@ed.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)

Learn more about this trial

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

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