Post-Surgery Wound Healing Tracking With MyHealthPal App

NCT07391735 | Recruiting DMC FDA Device

• 1 other identifier: 2025P003153
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Infection and Wound Healing

Outcome Measures

Primary Outcomes (6)

• Imageability

  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

  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

  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

  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

  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)

  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 Outcomes (8)

• Specificity

  From first enrollment to final subject's end of app usage at 16 weeks

• Sensitivity

  From first enrollment to final subject's end of app usage at 16 weeks

• Surgical Site Infection (SSI) Rate

  From first enrollment to final subject's end of app usage at 16 weeks

• Surgical Site Infection (SSI) Related Complications

  From first enrollment to final subject's end of app usage at 16 weeks

• Surgical Site Infection (SSI) Mortality Rate

  From first enrollment to final subject's end of app usage at 16 weeks

Study Arms (2)

MyHealthPal App Users

EXPERIMENTAL

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

Controls

NO INTERVENTION

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.

Interventions

MyHealthPal App DEVICE

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.

MyHealthPal App Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Spinal cord stimulator implantation
• Spinal cord stimulator explant
• Spinal cord stimulator revision
• Intrathecal pump implantation
• Intrathecal pump explant
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Pain Management Center - 850 Boylston St

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Olivia M Sutton, MD

  Brigham and Women's Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan L Cabral

CONTACT

617-732-9502; mlcabral@bwh.harvard.edu

Emma Feldman

CONTACT

617-732-9278; efeldman2@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 6, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)