The SurgiMend PRS Retrospective Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Reconstructive Surgical Procedures

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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SurgiMend PRS

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.

Intervention Type DEVICE

Other Intervention Names

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SurgiMend PRS Meshed

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes