Status:
COMPLETED
The SurgiMend PRS Retrospective Study
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Reconstructive Surgical Procedures
Eligibility:
FEMALE
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- The patient has reviewed the ethics-approved consent form and has provided consent for data collection
- Subject is a female over the age of 18 at the time of index surgery (mastectomy)
- Subject had mastectomy performed for cancer or as a cancer prophylaxis
- The surgical plan included one of the following approaches:
- Immediate unilateral or bilateral prepectoral DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skinreducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
- Immediate unilateral or bilateral submuscular DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skin-reducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
- If subject received bilateral breast reconstruction, the subject must have received the same surgical technique for both breasts including the implantation of SurgiMend® PRS or SurgiMend® PRS Meshed
- If subject received unilateral breast reconstruction, there was no surgical intervention on the contralateral breast within 12 months post-operatively
- Subject underwent mastectomy (index surgery) at a minimum of 24 months prior to study initiation at site
Exclusion
- The surgical plan included muscle flaps to supplement the breast mound
- The reconstruction plan included hybrid implant coverage with another type of mesh (e.g., use of another mesh or ADM in addition to SurgiMend®)
- Subject had received prior breast augmentation, mastopexy, or breast reduction surgeries (does not include breast biopsy)
- Subject was a user of any nicotine products (cigarettes, chewing tobacco, vapor, etc.) (within 6 weeks before index surgery)
- Subject had uncontrolled Type I or Type II diabetes (HbA1C \>9)
- Subject had previously undergone radiation therapy to the chest wall prior to index surgery
- Subject had been diagnosed with advanced stage disease (stage 3 or 4, or inflammatory cancer)
Key Trial Info
Start Date :
January 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05182177
Start Date
January 31 2022
End Date
December 31 2024
Last Update
February 14 2025
Active Locations (6)
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1
AULSS9 Scaligera
Verona, Veneto, Italy, 37122
2
Ospedale Regionale di Lugano; Sede Ospedale Italiano
Viganello, Switzerland
3
Royal Free Hospital
London, North West, United Kingdom, NW3 2GQ
4
Royal Hallamshire Hospital
Sheffield, Yorkshire, United Kingdom, S10 2JF