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

Completed

• Conditions: Reconstructive Surgery; Plastic Surgery

• Registration Number: NCT04195854
• Lead Sponsor: C. R. Bard

Brief 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.

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2019-12-17
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1183

Inclusion Criteria

• 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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-world utilization of P4HB scaffold	Anticipated 18 months	To obtain data from real-world utilization of P4HB scaffolds in order to evaluate how and why these products are being used and to assess the safety of these products

Secondary Outcome Measures

Name	Time	Method
Surgeon/patient satisfaction	Anticipated 18 months	To evaluate surgeon/patient satisfaction with the P4HB scaffold

Trial Locations

Locations (10)

Aesthetx; 🇺🇸 Campbell, California, United States

Revalla Plastic Surgery and Medical Aesthetics; 🇺🇸 Littleton, Colorado, United States

Southern Plastic Surgery; 🇺🇸 Duluth, Georgia, United States

HKB Cosmetic Surgery; 🇺🇸 Huntersville, North Carolina, United States

Aesthetic Plastic Surgical Institute; 🇺🇸 Laguna Beach, California, United States

Sarasota Plastic Surgery; 🇺🇸 Sarasota, Florida, United States

Park Cities Surgery; 🇺🇸 Dallas, Texas, United States

Meridian Plastic Surgery; 🇺🇸 Indianapolis, Indiana, United States

Belcara Health; 🇺🇸 Baltimore, Maryland, United States

Politis Plastic Surgery; 🇺🇸 Tampa, Florida, United States