Wound Infection and Wound HealingNCT07391735
Post-Surgery Wound Healing Tracking With MyHealthPal App
A study testing MyHealthPal App in people with Wound Infection and Wound Healing, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection and Wound Healing
- What is being tested?
- MyHealthPal App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Pain Management Center - 850 Boylston St
Chestnut Hill, Massachusetts, 02467
Meghan L Cabral, 617-732-9502, mlcabral@bwh.harvard.edu
Olivia M Sutton, MD
About this study
Official title: 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.
- Conditions
- Wound Infection and Wound Healing
- Being tested
- MyHealthPal App
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHealthPal AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment of first subject to 6 weeks post-operation of last subject
Secondary outcomes (8)
Specificity
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%.
Measured: From first enrollment to final subject's end of app usage at 16 weeks
Sensitivity
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%.
Measured: From first enrollment to final subject's end of app usage at 16 weeks
Surgical Site Infection (SSI) Rate
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.
Measured: From first enrollment to final subject's end of app usage at 16 weeks
Surgical Site Infection (SSI) Related Complications
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.
Measured: From first enrollment to final subject's end of app usage at 16 weeks
Surgical Site Infection (SSI) Mortality Rate
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.
Measured: From first enrollment to final subject's end of app usage at 16 weeks
Infection-Related Emergency Department Visits
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.
Measured: From first enrollment to final subject's end of app usage at 16 weeks
Infection-Related Hospital Readmissions
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.
Measured: From first enrollment to final subject's end of app usage at 16 weeks
Patient Satisfaction (16-Week Point)
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.
Measured: From first enrollment to final subject's end of app usage at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start27 Mar 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Infection and Wound HealingStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivia Sutton, Brigham and Women's Hospital
- Investigators
- Olivia M Sutton, MD, Principal investigator, Brigham and Women's Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391735
- Sponsor's protocol ID
- 2025P003153
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Procedure Patient Remote Monitoring With MyHealthPal Clinical Study
- ClinicalTrials.gov ID
- NCT07391735
- Acronym / sponsor ID
- 2025P003153
- Conditions
- Wound Infection and Wound Healing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyHealthPal App Users | Experimental | Device: MyHealthPal AppIf 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Ability to attend all standard surgery follow-up appointments at Brigham and Women's Hospital.
- Ability to understand and sign written informed consent documents.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyHealthPal AppMyHealthPal (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. | Device | MyHealthPal App Users |
Primary outcome
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.
8 secondary outcomes
Specificity
Time frame: 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
Surgical Site Infection (SSI) Rate
Time frame: 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
Surgical Site Infection (SSI) Mortality Rate
Time frame: 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
Infection-Related Hospital Readmissions
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivia M Sutton, MD principal investigator
Brigham and Women's Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyHealthPal App in people with Wound Infection and Wound Healing, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghan L Cabral (617-732-9502, mlcabral@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imageability (time frame: From enrollment to end of app usage at 16 weeks post-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.