NCT07391735 · Brigham and Women's Hospital
Post-Surgery Wound Healing Tracking With MyHealthPal App
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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%.
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%.
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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.
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
Where
- Chestnut Hill, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations