Clinical trial NCT05182177: The SurgiMend PRS Retrospective Study
Official title: A Multi-Center, Retrospective Review of Implant-Based Post Mastectomy Breast Reconstruction Utilizing SurgiMend® Collagen Matrix in Prepectoral and Submuscular Surgical Approaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reconstructive Surgical Procedures
Keywords: breast reconstruction
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected for 50 female subjects that have been implanted with SurgiMend® PRS and 50 female subjects that have been implanted with SurgiMend® PRS Meshed according to the IFU.

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 use.


Eligibility criteria: Inclusion Criteria:

1. The patient has reviewed the ethics-approved consent form and has provided consent for data collection
2. Subject is a female over the age of 18 at the time of index surgery (mastectomy)
3. Subject had mastectomy performed for cancer or as a cancer prophylaxis
4. The surgical plan included one of the following approaches:

   1. 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
   2. 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
5. 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
6. If subject received unilateral breast reconstruction, there was no surgical intervention on the contralateral breast within 12 months post-operatively
7. Subject underwent mastectomy (index surgery) at a minimum of 24 months prior to study initiation at site

Exclusion Criteria:

1. The surgical plan included muscle flaps to supplement the breast mound
2. The reconstruction plan included hybrid implant coverage with another type of mesh (e.g., use of another mesh or ADM in addition to SurgiMend®)
3. Subject had received prior breast augmentation, mastopexy, or breast reduction surgeries (does not include breast biopsy)
4. Subject was a user of any nicotine products (cigarettes, chewing tobacco, vapor, etc.) (within 6 weeks before index surgery)
5. Subject had uncontrolled Type I or Type II diabetes (HbA1C \>9)
6. Subject had previously undergone radiation therapy to the chest wall prior to index surgery
7. Subject had been diagnosed with advanced stage disease (stage 3 or 4, or inflammatory cancer)

Primary outcomes:
measure: Performance of SurgiMend
timeFrame: 24 months
Secondary outcomes:
measure: Safety of SurgiMend
timeFrame: 24 months
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AULSS9 Scaligera
state: Veneto
city: Viganello
country: Switzerland
facility: Ospedale Regionale di Lugano; Sede Ospedale Italiano
city: London
country: United Kingdom
facility: Royal Free Hospital
state: North West
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: Yorkshire
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
Study officials:
References: