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

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.

Study Overview

• Status: Completed
• Conditions: Plastic Surgery; Reconstructive Surgery
• Intervention / Treatment: Device: P4HB product

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 Type: Observational
• Enrollment (Actual): 1183

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Aesthetx
    • Laguna Beach, California, United States, 92651
      • Aesthetic Plastic Surgical Institute
  • Colorado
    • Littleton, Colorado, United States, 80122
      • Revalla Plastic Surgery and Medical Aesthetics
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Plastic Surgery
    • Tampa, Florida, United States, 33607
      • Politis Plastic Surgery
  • Georgia
    • Duluth, Georgia, United States, 30096
      • Southern Plastic Surgery
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Meridian Plastic Surgery
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Belcara Health
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • HKB Cosmetic Surgery
  • Texas
    • Dallas, Texas, United States, 75205
      • Park Cities Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients greater than or equal to 18 years of age who underwent plastic or reconstructive surgical procedure with P4HB on or after January 1, 2014 until the date of site initiated data collection and who have at least 1 visit of documented post-procedure follow-up

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world utilization of P4HB scaffold	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	Anticipated 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon/patient satisfaction	To evaluate surgeon/patient satisfaction with the P4HB scaffold	Anticipated 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Product	Type of procedure, reason for procedure, surgical approach tissue assessment, use of other medical devices, concomitant procedures, use of fat grafting	Anticipated 18 months
Safety - adverse and serious adverse events	Adverse events and serious adverse events related to the study device or procedure, or occurring at procedure anatomy. Medications used in treatment of adverse events	Anticipated 18 months
Follow up visits	Assessment of healing, menopausal status, Weight, BMI	Anticipated 18 months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Collaborators: Tepha, Inc.
• Investigators: Study Director: K Doyle, Tepha, Inc/Galatea Surgical

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2019
• Primary Completion (ACTUAL): January 31, 2022
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (ACTUAL): December 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CP-1060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes