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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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:\n\n1. 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).\n2. At least one image of their surgical wound(s).\n\nPatients 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technology acceptance', 'timeFrame': '30 days', 'description': 'Technology Intervention acceptance as measured by Telehealth Usability Questionnaire (TUQ)'}], 'secondaryOutcomes': [{'measure': 'Health service usage', 'timeFrame': '30 days', 'description': 'Attendance at community (general practice) or emergency hospital services (emergency department or the surgical treatment centre)'}, {'measure': 'Time-to-diagnosis (days) of surgical-site infection', 'timeFrame': '30 days', 'description': 'Time-to-diagnosis (days) of surgical-site infection (CDC criteria)'}, {'measure': 'surgical-site infection interventions', 'timeFrame': '30 days', 'description': 'Therapeutic intervention received for surgical site infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Implementation'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '39434121', 'type': 'DERIVED', 'citation': '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': '37147462', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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".', 'detailedDescription': '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.\n\nThis 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.\n\nAll 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.\n\nOn 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age ≥ 16 years) with the capacity to provide informed consent\n* Patient undergoing abdominal surgery who own a smartphone capable of accessing and completing the online response form\n\nExclusion Criteria:\n\n* 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).'}, 'identificationModule': {'nctId': 'NCT05069103', 'acronym': 'INROADE', 'briefTitle': 'ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic', 'orgStudyIdInfo': {'id': 'AC21032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '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:\n\n1. 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).\n2. At least one image of their surgical wound(s).\n\nPatients 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.', 'interventionNames': ['Device: Intervention']}], 'interventions': [{'name': 'Intervention', 'type': 'DEVICE', '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:\n\n1. 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).\n2. At least one image of their surgical wound(s).', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'One year following publication', 'ipdSharing': 'YES', 'description': 'Anonomysed IPD shared for research purposes', 'accessCriteria': 'Request from chief investigator (Professor Ewen Harrison)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'ISLACARE LTD (12108076)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}