NCT04195854

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

STARS-R Registry: A Retrospective Observational Registry Evaluating the Use of P4HB Scaffolds for Soft Tissue Support in Plastic And Reconstructive Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,183 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of P4HB products. Adults greater than or equal to 18 years old who have undergone a plastic or reconstructive surgical procedure with P4HB on or after January 1, 2014, will be identified using the centers' medical records. Data on patient demographics, relevant medical history, product and procedure used, product safety, and subjective and objective outcome measures will be collected. The data may be used in publication and education and may inform future product development including future clinical trials. The trial will include all consecutive participants who meet inclusion/exclusion criteria with the goal of having up to 5000 participants. A screening log will be kept at the site of all participants screened regardless of whether or not they were included in the analysis. Participants will be entered into the database based on the consecutive group meeting enrollment criteria. The overall purpose of this study is to gain an understanding of the use and safety of treatments on a historic collection basis. Hypothesis testing is not necessary for the statistical analyses of the generated data. Broad inclusion criteria with few exclusion criteria are utilized so as to avoid censoring historic real-world use of the device.

Conditions

• Plastic Surgery
• Reconstructive Surgery

Interventions

Type	Name	Description
DEVICE	P4HB product	Retrospective use of P4HB in various anatomies

Timeline

• Start date: 2019-12-17
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2019-12-12
• Last updated: 2022-02-04

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study