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
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01204554 -
Microcirculation in Perforator Flaps. Enhancing Tissue Survival
|
Phase 0 | |
| Completed |
NCT00872859 -
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
|
Phase 4 | |
| Completed |
NCT05267197 -
3D Telemedicine: A Clinician Feedback Study
|
||
| Completed |
NCT02411292 -
Enoxaparin Metabolism in Reconstructive Surgery Patients
|
Phase 2 | |
| Completed |
NCT04002713 -
Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer
|
||
| Completed |
NCT03212365 -
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
|
Phase 2 | |
| Recruiting |
NCT05032768 -
The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
|
||
| Recruiting |
NCT04261829 -
AFT: Introduction of a Full Breast Reconstructive Method
|
||
| Completed |
NCT06447610 -
Lateral Arm Free Flap: a Useful Flap in the Maxillo-facial Surgeon's Therapeutic Armory, Case Series
|
||
| Recruiting |
NCT03899051 -
PRF and Connective Tissue Graft in Interdental Papilla Reconstruction
|
N/A | |
| Terminated |
NCT01681797 -
Fluorescence Angiography: Planning and Monitoring of Perforator Flaps
|
N/A | |
| Not yet recruiting |
NCT02089490 -
Evaluation of NEVELIA® in Terms of Safety and Efficacy for Third-degree Burns Treatment or Reconstructive Surgery
|
N/A |