Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:08 AM
Study NCT ID:
NCT07391735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Surgery Wound Healing Tracking With MyHealthPal App
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Imageability', 'timeFrame': 'From enrollment to end of app usage at 16 weeks post-surgery', 'description': "Imageability is defined as the percentage of wound incision photos that received an surgical site infection (SSI) risk prediction (high enough quality photos) by the MyHealthPal (MHP) app artificial intelligence algorithm among all photos uploaded by patients. High imageability is a critical step in MHP's predictive effectiveness. MHP Patient app guides patients on how to take surgical incision photos that are high enough quality for analysis. Target imageability percentage is greater than or equal to 95%."}, {'measure': 'Positive/negative percent agreement', 'timeFrame': 'From enrollment to end of app usage at 16 weeks post-surgery', 'description': 'Positive/negative percent agreement will be sought for each MyHealthPal (MHP) prediction by receiving feedback from one of the study investigators. The investigator will be prompted to agree or disagree with each MHP prediction (elevated or standard risk for a surgical site infection, or SSI). Final positive/negative agreement percentage will be calculated after the last subject completes the 16-week study period. The objective threshold for agreement percentage is \\>90%.'}, {'measure': 'Patient Usage/Data Entry', 'timeFrame': 'From enrollment to end of app usage at 16 weeks post-surgery', 'description': 'MyHealthPal (MHP) effectiveness is directly dependent on patient use and data entry. This study aims to demonstrate \\>70% patient compliance with the monitoring plan data entry requirements. Patient compliance with data entry will be calculated by input category, wound photo, wound inputs, vital signs, medication adherence, and well-being, as well as overall patient compliance with all data entry requirements that are defined in the patient monitoring plan.'}, {'measure': 'Clinician Feedback', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': "When clinicians agree or disagree with the MyHealthPal (MHP) app's prediction, they are encouraged to submit their feedback on incision characteristics that they observe in the photos. This feedback is particularly helpful in identifying early/leading indicators of surgical site infections (SSIs). In this study, an objective is for clinicians to submit their comments greater than or equal to 95% of the time they have agreed or disagreed with a prediction."}, {'measure': 'Safety Risk', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': "MyHealthPal (MHP) is a digital platform that complements current patient care and does not impact the standard of care. Nevertheless, one of the study's objectives is to confirm that MHP use does not pose any patient safety risks. Risk factors for affected wound healing will be recorded for both the control and MyHealthPal app group as well as surgical site infection rates in both groups. Data from patients with similar risk factors across both groups will be compared to ensure that there is not a significant difference in infection incidence when MHP usage is a factor in post-operative wound monitoring."}], 'secondaryOutcomes': [{'measure': 'Specificity', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': 'Specificity measurement refers to the comparison of the MyHealthPal (MHP) application predictions against a reference standard. In this study, the reference standard will be an infection diagnosis by a study investigator (classified as definite or probable). Specificity refers to how often the test is negative when the condition of interest is absent. For this study, a negative new test is a standard risk prediction, while positive new test is an elevated risk prediction. True positive or true negative events (infection or no infection) will be determined by an investigator through standard clinical diagnostic tests. A secondary objective is calculated specificity to be equal to or greater than 85%.'}, {'measure': 'Sensitivity', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': 'Sensitivity refers to how often the test is positive when the condition of interest is present. In this study, the reference standard will be an infection diagnosis by a study investigator (classified as definite or probable). For this study, a negative new test is a standard risk prediction, while positive new test is an elevated risk prediction. True positive or true negative events (infection or no infection) will be determined by an investigator through standard clinical diagnostic tests. A secondary objective is calculated sensitivity to be equal to or greater than 85%.'}, {'measure': 'Surgical Site Infection (SSI) Rate', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': 'Another secondary objective is to measure the rate of surgical site infections (SSIs) in participants using the MyHealthPal (MHP) app in comparison to non-app participants. There should be no change in number of SSIs between groups as MHP is not an SSI prevention tool.'}, {'measure': 'Surgical Site Infection (SSI) Related Complications', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': 'Another secondary objective is to measure number of surgical site infection (SSI) related complications when using the MyHealthPal (MHP) app in comparison to non-app participants. There should be a reduction in the number of SSI-related complications in the MHP group.'}, {'measure': 'Surgical Site Infection (SSI) Mortality Rate', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': 'Another secondary objective is to measure the SSI mortality rate in participants using the MyHealthPal (MHP) app and non-app participants. There should be a reduction in the SSI mortality rate in the MHP group.'}, {'measure': 'Infection-Related Emergency Department Visits', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': 'Another study measure is the amount of infection-related visits to the Emergency Department (ED) and hours spent there. There should be a reduction in ED visits and time spent at the ED in the MyHealthPal (MHP) group.'}, {'measure': 'Infection-Related Hospital Readmissions', 'timeFrame': "From first enrollment to final subject's end of app usage at 16 weeks", 'description': 'Another study measure is the number of infection-related readmissions to the hospital and days spent admitted. There should be a reduction innumber of readmissions and days spent admitted in the MyHealthPal (MHP) group.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wound Infection and Wound Healing']}, 'descriptionModule': {'briefSummary': "The investigators want to explore the use of a smartphone app that allows patients to take photos of their wounds in early stages of healing, so that clinicians can monitor wound-healing remotely with the assistance of an AI program.\n\nParticipants will choose whether they want to be in the control group or the app group. Participants in the app group will be asked to download an app on their personal smartphone before their surgery. After the procedure, participants will upload a photo of their surgery site as well as answer some questions about its characteristics either on a daily or weekly basis. A healthcare provider and the app's AI algorithm will observe this information to determine the risk of infection. Participants in the control group will not be asked to use the app. Their medical record will be monitored by study staff intermittently to see if they develop infection. This study will take approximately 16 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (18 years old and older).\n* Ability to understand consent process and questionnaires. Patients with ready access to a smartphone, compatible smart device (operating system 5.0 version, also known as Lollipop, for Android and 13 or later version for iOS), smartphone aptitude, smartphone with sufficient memory space for the relevant app, and willingness to participate in the study as assessed by a questionnaire.\n* Patients undergoing one of the following surgeries within the Brigham and Women's Pain Management Practice:\n\n 1. Spinal cord stimulator implantation\n 2. Spinal cord stimulator explant\n 3. Spinal cord stimulator revision\n 4. Intrathecal pump implantation\n 5. Intrathecal pump explant\n 6. Intrathecal pump revision\n* Ability to attend all standard surgery follow-up appointments at Brigham and Women's Hospital.\n* Ability to understand and sign written informed consent documents.\n\nExclusion Criteria:\n\n* Cognitive or physical impairment that would prevent patient from entering data in MHP.\n* Any acute or chronic condition that would limit the ability of the patient to participate in the study.\n* Any patient who is experiencing an ongoing infection prior to undergoing a surgical revision/explant"}, 'identificationModule': {'nctId': 'NCT07391735', 'briefTitle': 'Post-Surgery Wound Healing Tracking With MyHealthPal App', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Postoperative Pain Procedure Patient Remote Monitoring With MyHealthPal Clinical Study', 'orgStudyIdInfo': {'id': '2025P003153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MyHealthPal App Users', 'description': 'If a participant chooses to be in the app study group, they will be provided with training materials on the MyHealthPal app. After set-up is complete, they will be asked to complete a quick survey on how the set-up went. One day after their surgical procedure (defined as Day 1), the participant will begin using the MyHealthPal app on their smartphone. For the first 14 days, they will upload a photo of their surgical wound each day and answer a few questions about their wound and how they are feeling. After the first 2 weeks, they will upload a photo of their surgical wound and answer the same questions once every week for 4 months. The participant will be asked to complete two more surveys regarding their opinion of the app. The app will use the photos and answers to track wound healing and assess risk of infection. It will use AI to assess risk, and that assessment will be sent to the provider to confirm its accuracy. The app will be used to track wound healing remotely.', 'interventionNames': ['Device: MyHealthPal App']}, {'type': 'NO_INTERVENTION', 'label': 'Controls'}], 'interventions': [{'name': 'MyHealthPal App', 'type': 'DEVICE', 'description': "MyHealthPal (MHP) is a digital platform for postoperative patients to analyze surgical wound characteristics remotely through photos and additional patient data to provide physicians with SSI risk predictions and inform clinical decision making. It allows postoperative patients to capture and upload wound photos and enter surgery-related medication intake (antibiotics, painkillers), vital signs, wound inputs, and well-being patient data. Patients and providers can access the mobile applications using their own smart devices, while healthcare providers can access the desktop portal through a personal computer. MHP provides a prediction report for healthcare providers anytime a patient enters any data. If the patient uploads a high quality surgical incision photo, MHP's prediction reports include an SSI risk prediction: elevated risk or standard risk. MHP's AI-based algorithm analyzes wound photos for characteristics indicative of infection and provides risk predictions for providers.", 'armGroupLabels': ['MyHealthPal App Users']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Meghan L Cabral', 'role': 'CONTACT', 'email': 'mlcabral@bwh.harvard.edu', 'phone': '617-732-9502'}, {'name': 'Emma Feldman', 'role': 'CONTACT', 'email': 'efeldman2@bwh.harvard.edu', 'phone': '617-732-9278'}], 'overallOfficials': [{'name': 'Olivia M Sutton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Anesthesiology Department"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Olivia Sutton', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}