Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05069103
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborators:
Medical Research Council
ISLACARE LTD (12108076)
Information provided by (Responsible Party):
University of Edinburgh

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".

Condition or disease Intervention/treatment Phase
Surgical Site Infection Device: Intervention Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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:

  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.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic
Actual Study Start Date : July 5, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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:

  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

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).




Primary Outcome Measures :
  1. Technology acceptance [ Time Frame: 30 days ]
    Technology Intervention acceptance as measured by Telehealth Usability Questionnaire (TUQ)


Secondary Outcome Measures :
  1. Health service usage [ Time Frame: 30 days ]
    Attendance at community (general practice) or emergency hospital services (emergency department or the surgical treatment centre)

  2. Time-to-diagnosis (days) of surgical-site infection [ Time Frame: 30 days ]
    Time-to-diagnosis (days) of surgical-site infection (CDC criteria)

  3. surgical-site infection interventions [ Time Frame: 30 days ]
    Therapeutic intervention received for surgical site infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069103


Contacts
Layout table for location contacts
Contact: Ewen M Harrison, MBChB, PhD 01312423614 ewen.harrison@ed.ac.uk

Locations
Layout table for location information
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Ewen M Harrison, MBChB, PhD    0131 242 3614    ewen.harrison@ed.ac.uk   
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Mark A Potter, MBChB    0131 242 3614    mark.potter@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
Medical Research Council
ISLACARE LTD (12108076)
Layout table for additonal information
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT05069103    
Other Study ID Numbers: AC21032
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonomysed IPD shared for research purposes
Supporting Materials: Study Protocol
Analytic Code
Time Frame: One year following publication
Access Criteria: Request from chief investigator (Professor Ewen Harrison)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
Telemedicine
Implementation
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Surgical Wound Infection
Surgical Wound
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries