A pilot randomized controlled study conducted at Cedars-Sinai Medical Center in Los Angeles, led by Prof. Alexandre Lellouch, designed to evaluate Pixacare-enabled remote monitoring compared to conventional follow-up in 60 patients after plastic surgery.
Study framework
Pilot study conducted at Cedars-Sinai Medical Center in Los Angeles, one of the most prestigious academic medical centers in the United States. Principal investigator: Prof. Alexandre Lellouch, Department of Plastic Surgery. Sponsor: Pixacare. Institutional Review Board (IRB) submission in progress.
Timeline
- Total enrollment: 60 patients
- Follow-up per patient: 3 months
- Total study duration: 6 months
- Status: IRB submission in progress
Study design
Prospective, randomized, single-center pilot study. First evaluation of Pixacare in a leading American academic medical center, with a view to international validation and expansion of clinical use in the United States.
Center and patients
The study includes 60 adult patients followed at Cedars-Sinai Medical Center after plastic or reconstructive surgery: body lift, breast reduction, or reconstructive procedures. Two postoperative follow-up modalities are compared:
- Standard care plus Pixacare-enabled remote monitoring
- Conventional in-person follow-up
Primary objective
The study evaluates patient satisfaction at 3 months between the two follow-up modalities (remote monitoring versus in-person consultations only).
Secondary objectives
The study also explores several complementary dimensions:
- Number of in-person consultations avoided
- Incidence of postoperative complications (local infections, wound deterioration)
- Time to wound healing
- Unplanned healthcare utilization (emergency department visits, wound-related hospitalizations)
- Patient adherence to the digital solution
Why this study
The international expansion of Pixacare's clinical evaluation requires validation in a leading American academic medical center. Cedars-Sinai Medical Center, consistently ranked among the top hospitals in the United States, provides a reference setting for this validation.
The pilot study paves the way for broader deployment in the United States, on a medico-economic market distinct from the French context. It also complements the evaluation of Pixacare in plastic surgery, following the foundational work of Kuster et al. 2021 on time savings in medical photography.
Keywords
Plastic surgery, remote monitoring, postoperative follow-up, patient satisfaction, randomized controlled trial, digital medical device
Références
- Cedars-Sinai pilot study — Evaluation of Pixacare-enabled remote monitoring versus conventional follow-up in postoperative plastic surgery. Pilot randomized controlled trial, 60 patients. Principal investigator: Prof. Alexandre Lellouch, Cedars-Sinai Medical Center, Los Angeles. Sponsor: Pixacare. IRB submission in progress.
- Related earlier work in plastic surgery: Kuster C, Ruffenach L, Dissaux C, Bruant-Rodier C, Bodin F. Photographies médicales : gain de temps et sécurité des données grâce à une application smartphone dédiée. Annales de Chirurgie Plastique Esthétique. 2021 June;66(3):217-222.