Clinical trial NCT04195854: STARS-R Registry: Retrospective Analysis of Poly-4-hydroxybutyrate (P4HB) Scaffold Use
Official title: STARS-R Registry: A Retrospective Observational Registry Evaluating the Use of P4HB Scaffolds for Soft Tissue Support in Plastic And Reconstructive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plastic Surgery
Reconstructive Surgery
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Tepha, Inc.
First posted: 2019-12-12
Enrollment: 1183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Real-world utilization of P4HB scaffold
timeFrame: Anticipated 18 months
Secondary outcomes:
measure: Surgeon/patient satisfaction
timeFrame: Anticipated 18 months
Other outcomes:
measure: Use of Product
timeFrame: Anticipated 18 months
measure: Safety - adverse and serious adverse events
timeFrame: Anticipated 18 months
measure: Follow up visits
timeFrame: Anticipated 18 months
Locations:
city: Campbell
country: United States
facility: Aesthetx
state: California
city: Laguna Beach
country: United States
facility: Aesthetic Plastic Surgical Institute
state: California
city: Littleton
country: United States
facility: Revalla Plastic Surgery and Medical Aesthetics
state: Colorado
city: Sarasota
country: United States
facility: Sarasota Plastic Surgery
state: Florida
city: Tampa
country: United States
facility: Politis Plastic Surgery
state: Florida
city: Duluth
country: United States
facility: Southern Plastic Surgery
state: Georgia
city: Indianapolis
country: United States
facility: Meridian Plastic Surgery
state: Indiana
city: Baltimore
country: United States
facility: Belcara Health
state: Maryland
city: Huntersville
country: United States
facility: HKB Cosmetic Surgery
state: North Carolina
city: Dallas
country: United States
facility: Park Cities Surgery
state: Texas
Study officials:
affiliation: Tepha, Inc/Galatea Surgical
name: K Doyle
role: STUDY_DIRECTOR
References: