Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 6:20 AM
Study NCT ID:
NCT05069103
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic
Sponsor:
University of Edinburgh
Organization:
Study Overview
Official Title:
ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INROADE
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. 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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: