The SurgiMend PRS Retrospective Study

Last updated: February 13, 2025
Sponsor: Integra LifeSciences Corporation
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

SurgiMend PRS

Clinical Study ID

NCT05182177
T-SUPORT-001
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. The patient has reviewed the ethics-approved consent form and has provided consentfor 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:

  5. 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

  6. 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

  7. 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

  8. If subject received unilateral breast reconstruction, there was no surgicalintervention on the contralateral breast within 12 months post-operatively

  9. Subject underwent mastectomy (index surgery) at a minimum of 24 months prior tostudy initiation at site

Exclusion

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 reductionsurgeries (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 indexsurgery

  7. Subject had been diagnosed with advanced stage disease (stage 3 or 4, orinflammatory cancer)

Study Design

Total Participants: 84
Treatment Group(s): 1
Primary Treatment: SurgiMend PRS
Phase:
Study Start date:
January 31, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Ospedale di Esine

    Esine, Brescia 25040
    Italy

    Site Not Available

  • AULSS9 Scaligera

    Verona, Veneto 37122
    Italy

    Site Not Available

  • Clinique des Grangettes

    Geneva,
    Switzerland

    Site Not Available

  • Ospedale Regionale di Lugano; Sede Ospedale Italiano

    Viganello,
    Switzerland

    Site Not Available

  • Princess Royal University Hospital

    Orpington, London BR6 8ND
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, North West NW3 2GQ
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield, Yorkshire S10 2JF
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • North Manchester General Hospital

    Manchester,
    United Kingdom

    Site Not Available

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