CompletedNot Applicable

The SurgiMend PRS Retrospective Study

Italy, Switzerland, United Kingdom84 participantsStarted 2022-01-31

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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

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 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)

What they're measuring

Performance of SurgiMend

Timeframe: 24 months

Trial details

NCT IDNCT05182177

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Reconstructive Surgical Procedures trials