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Purpose

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. Participants 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults (18 years old and older). - 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. - Patients undergoing one of the following surgeries within the Brigham and Women's Pain Management Practice: 1. Spinal cord stimulator implantation 2. Spinal cord stimulator explant 3. Spinal cord stimulator revision 4. Intrathecal pump implantation 5. Intrathecal pump explant 6. Intrathecal pump revision - Ability to attend all standard surgery follow-up appointments at Brigham and Women's Hospital. - Ability to understand and sign written informed consent documents.

Exclusion Criteria

  • Cognitive or physical impairment that would prevent patient from entering data in MHP. - Any acute or chronic condition that would limit the ability of the patient to participate in the study. - Any patient who is experiencing an ongoing infection prior to undergoing a surgical revision/explant

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MyHealthPal App Users 		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.
  • Device: MyHealthPal App
    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.
No Intervention
Controls 		Control participants will be required to complete one patient satisfaction survey six weeks post-operation, and will be given the choice to complete a second satisfaction survey sixteen weeks post-operation.

Recruiting Locations

Brigham and Women's Pain Management Center - 850 Boylston St
Chestnut Hill, Massachusetts 02467
Contact:
Meghan L Cabral
617-732-9502
mlcabral@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Meghan L Cabral
617-732-9502
mlcabral@bwh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.