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Recruiting NCT07391735

Post-Surgery Wound Healing Tracking With MyHealthPal App

No phase Interventional Wound Infection and Wound Healing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MyHealthPal App.
Who it may be relevant to
Registry conditions: Wound Infection and Wound Healing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Postoperative Pain Procedure Patient Remote Monitoring With MyHealthPal Clinical Study

Overview

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

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • 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]

Eligibility 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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Brigham and Women's Pain Management Center - 850 Boylston St — Chestnut Hill

Identifiers

NCT: NCT07391735 · 2025P003153

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗