Recruiting

Wound Monitoring App

Sponsor:

Brigham and Women's Hospital

Code:

NCT07391735

Conditions

Wound Infection and Wound Healing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MyHealthPal App

Study Details

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

Study ID

NCT07391735

Start date

Mar 27, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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. After wound dressings are removed at the post-op visit, the participant will begin using the MyHealthPal app on their smartphone. For about 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 Day 21 (21 days after the surgery), they will upload a photo of their surgical wound and answer the same questions once every week for 4 months. 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 participant will be asked to complete four more surveys regarding their opinion of the app and their post-op care.

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.

Interventions

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.

Primary outcome measure

  • Imageability [ Time Frame: 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 ]
  • Patient Usage/Data Entry [ Time Frame: 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 ]
  • Safety Risk [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Meghan L Cabral

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

Locations

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

Recruiting

Chestnut Hill, Massachusetts, United States, 02467

Contacts

Meghan L Cabral

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

Principal Investigator:

Olivia M Sutton, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-08-12.