Using MyHealthPal to track wound healing after spinal or intrathecal pump surgery
Postoperative Pain Procedure Patient Remote Monitoring With MyHealthPal Clinical Study
This project tries a smartphone app that lets adults who had spinal cord stimulator or intrathecal pump procedures send photos of their surgical wound so clinicians and an AI can watch for early infection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Chestnut Hill, Massachusetts) |
| Trial ID | NCT07391735 on ClinicalTrials.gov |
What this trial studies
Participants choose whether to use the MyHealthPal app or receive standard follow-up. App users download the app before surgery and upload wound photos and short symptom questionnaires on a daily or weekly schedule after their procedure. A healthcare provider together with the app's AI algorithm reviews images and responses to estimate infection risk, while control participants have their medical records monitored intermittently for infections. The study lasts about 16 weeks and is conducted at Brigham and Women's Pain Management Center.
Who should consider this trial
Good fit: Adults (18+) having spinal cord stimulator implantation, explantation or revision, or intrathecal pump implantation, explantation or revision at Brigham and Women's who can use a compatible smartphone and attend standard follow-up visits are ideal candidates.
Not a fit: People without a compatible smartphone, with cognitive or physical impairments that prevent using the app, or those not undergoing the listed procedures are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the app could enable earlier detection of wound infections so patients get treatment sooner and avoid complications.
How similar studies have performed: Other programs and early research using patient-taken wound photos and AI-assisted review have shown promise for earlier detection of problems, though they are not yet universally adopted as standard care.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chestnut Hill, Massachusetts
- Brigham and Women's Pain Management Center - 850 Boylston St — Chestnut Hill, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Olivia M Sutton, MD — Brigham and Women's Anesthesiology Department
- Study coordinator: Meghan L Cabral
- Email: mlcabral@bwh.harvard.edu
- Phone: 617-732-9502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.