The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
Study Type
OBSERVATIONAL
Enrollment
84
SurgiMend® PRS and SurgiMend® PRS Meshed are intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® PRS and SurgiMend® PRS Meshed are specifically indicated for plastic and reconstructive surgery, including breast reconstruction.
AULSS9 Scaligera
Verona, Veneto, Italy
Ospedale Regionale di Lugano; Sede Ospedale Italiano
Viganello, Switzerland
Royal Free Hospital
London, North West, United Kingdom
Royal Hallamshire Hospital
Sheffield, Yorkshire, United Kingdom
Performance of SurgiMend
The primary endpoint of this study is the proportion of patients who did not require additional surgical interventions at or associated with the site of the original reconstruction within 12 months after SurgiMend® PRS or SurgiMend® PRS Meshed implantation.
Time frame: 24 months
Safety of SurgiMend
The secondary endpoint of this study is the occurrence of relevant (S)AEs within 12 months of SurgiMend® PRS or SurgiMend® PRS Meshed implantation.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
North Manchester General Hospital
Manchester, United Kingdom