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

Reconstructive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195854
• Other study ID #: CP-1060
• Status: Completed
• Start date: December 17, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1183
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plastic Surgery
• Reconstructive Surgery

Intervention

Device:
• P4HB product
Retrospective use of P4HB in various anatomies

Locations

Country	Name	City	State
United States	Belcara Health	Baltimore	Maryland
United States	Aesthetx	Campbell	California
United States	Park Cities Surgery	Dallas	Texas
United States	Southern Plastic Surgery	Duluth	Georgia
United States	HKB Cosmetic Surgery	Huntersville	North Carolina
United States	Meridian Plastic Surgery	Indianapolis	Indiana
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

Sponsors (2)

Lead Sponsor	Collaborator
C. R. Bard	Tepha, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Follow up visits	Assessment of healing, menopausal status, Weight, BMI	Anticipated 18 months
Primary	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	Surgeon/patient satisfaction	To evaluate surgeon/patient satisfaction with the P4HB scaffold	Anticipated 18 months