Post-Surgery Wound Healing Tracking With MyHealthPal App

April 13, 2026 updated by: Olivia Sutton, Brigham and Women's Hospital

Postoperative Pain Procedure Patient Remote Monitoring With MyHealthPal Clinical Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Recruiting
        • Brigham and Women's Pain Management Center - 850 Boylston St
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olivia M Sutton, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imageability
Time Frame: From enrollment to end of app usage at 16 weeks post-surgery
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%.
From enrollment to end of app usage at 16 weeks post-surgery
Positive/negative percent agreement
Time Frame: From enrollment to end of app usage at 16 weeks post-surgery
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%.
From enrollment to end of app usage at 16 weeks post-surgery
Patient Usage/Data Entry
Time Frame: From enrollment to end of app usage at 16 weeks post-surgery
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.
From enrollment to end of app usage at 16 weeks post-surgery
Clinician Feedback
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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.
From first enrollment to final subject's end of app usage at 16 weeks
Safety Risk
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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.
From first enrollment to final subject's end of app usage at 16 weeks
Patient Satisfaction (6-Week Point)
Time Frame: From enrollment of first subject to 6 weeks post-operation of last subject
The final primary objective is to measure patient satisfaction at the 6-week post-operation visit, which is typically the final follow-up visit for operation recovery per the Pain Management Clinic's standard of care. By having controls and app users complete this survey at the 6-Week mark, the level of satisfaction with their care can be compared; this study aims to demonstrate that the added tracking via MyHealthPal will increase patient comfortability and satisfaction with post-operative care.
From enrollment of first subject to 6 weeks post-operation of last subject

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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%.
From first enrollment to final subject's end of app usage at 16 weeks
Sensitivity
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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%.
From first enrollment to final subject's end of app usage at 16 weeks
Surgical Site Infection (SSI) Rate
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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.
From first enrollment to final subject's end of app usage at 16 weeks
Surgical Site Infection (SSI) Related Complications
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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.
From first enrollment to final subject's end of app usage at 16 weeks
Surgical Site Infection (SSI) Mortality Rate
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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.
From first enrollment to final subject's end of app usage at 16 weeks
Infection-Related Emergency Department Visits
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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.
From first enrollment to final subject's end of app usage at 16 weeks
Infection-Related Hospital Readmissions
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
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.
From first enrollment to final subject's end of app usage at 16 weeks
Patient Satisfaction (16-Week Point)
Time Frame: From first enrollment to final subject's end of app usage at 16 weeks
A secondary objective will be measuring patient satisfaction in post-operative care at the 16-Week post-operation study endpoint. As this is ten weeks past the standard of care final visit, this survey will be optional for control subjects.
From first enrollment to final subject's end of app usage at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Olivia M Sutton, MD, Brigham and Women's Anesthesiology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P003153

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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