STARS-R Registry: Retrospective Analysis of Poly-4-hydroxybutyrate (P4HB) Scaffold Use

Completed

Conditions studied: Plastic Surgery, Reconstructive Surgery

In brief

This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of the P4HB scaffold. Data on patient demographics, relevant medical history, product and procedure used, product safety, and outcome measures will be collected as available.

Key facts

Study ID

NCT04195854

Run by

C. R. Bard

People needed

1183

Starts

2019-12-17

Expected to finish

2022-01-31

Last updated by the study team

2022-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 18 years old
• Underwent plastic or reconstructive surgical procedure with P4HB on or after January 1, 2014 until the date of site initiated data collection
• At least 1 visit of documented post-procedure follow-up

You may not qualify if…

• None

Where it is running

• Aesthetx — Campbell, California, United States
• Aesthetic Plastic Surgical Institute — Laguna Beach, California, United States
• Revalla Plastic Surgery and Medical Aesthetics — Littleton, Colorado, United States
• Sarasota Plastic Surgery — Sarasota, Florida, United States
• Politis Plastic Surgery — Tampa, Florida, United States
• Southern Plastic Surgery — Duluth, Georgia, United States
• Meridian Plastic Surgery — Indianapolis, Indiana, United States
• Belcara Health — Baltimore, Maryland, United States
• HKB Cosmetic Surgery — Huntersville, North Carolina, United States
• Park Cities Surgery — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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