Plastic Surgery, Reconstructive Surgery
Conditions
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.
Interventions
DEVICEP4HB product
Retrospective use of P4HB in various anatomies
Sponsors
Tepha, Inc.
C. R. Bard
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Surgeon/patient satisfaction | Anticipated 18 months | To evaluate surgeon/patient satisfaction with the P4HB scaffold |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of Product | Anticipated 18 months | Type of procedure, reason for procedure, surgical approach tissue assessment, use of other medical devices, concomitant procedures, use of fat grafting |
| Safety - adverse and serious adverse events | Anticipated 18 months | 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 |
| Follow up visits | Anticipated 18 months | Assessment of healing, menopausal status, Weight, BMI |
Countries
United States
Outcome results
None listed