Phase
Condition
N/ATreatment
SurgiMend PRS
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient has reviewed the ethics-approved consent form and has provided consentfor 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 reconstructionfollowing nipple-sparing, skin-sparing, or skinreducing mastectomy with the useof SurgiMend® PRS or SurgiMend® PRS Meshed
Immediate unilateral or bilateral submuscular DTI or TE/I breast reconstructionfollowing nipple-sparing, skin-sparing, or skin-reducing mastectomy with theuse of SurgiMend® PRS or SurgiMend® PRS Meshed
If subject received bilateral breast reconstruction, the subject must have receivedthe same surgical technique for both breasts including the implantation ofSurgiMend® PRS or SurgiMend® PRS Meshed
If subject received unilateral breast reconstruction, there was no surgicalintervention on the contralateral breast within 12 months post-operatively
Subject underwent mastectomy (index surgery) at a minimum of 24 months prior tostudy initiation at site
Exclusion
Exclusion Criteria:
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 reductionsurgeries (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 indexsurgery
Subject had been diagnosed with advanced stage disease (stage 3 or 4, orinflammatory cancer)
Study Design
Connect with a study center
Ospedale di Esine
Esine, Brescia 25040
ItalySite Not Available
AULSS9 Scaligera
Verona, Veneto 37122
ItalySite Not Available
Clinique des Grangettes
Geneva,
SwitzerlandSite Not Available
Ospedale Regionale di Lugano; Sede Ospedale Italiano
Viganello,
SwitzerlandSite Not Available
Princess Royal University Hospital
Orpington, London BR6 8ND
United KingdomSite Not Available
Royal Free Hospital
London, North West NW3 2GQ
United KingdomSite Not Available
Royal Hallamshire Hospital
Sheffield, Yorkshire S10 2JF
United KingdomSite Not Available
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
United KingdomSite Not Available
North Manchester General Hospital
Manchester,
United KingdomSite Not Available
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