The SurgiMend PRS Retrospective Study

A Multi-Center, Retrospective Review of Implant-Based Post Mastectomy Breast Reconstruction Utilizing SurgiMend® Collagen Matrix in Prepectoral and Submuscular Surgical Approaches

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.

Study Overview

• Status: Completed
• Conditions: Reconstructive Surgical Procedures
• Intervention / Treatment: Device: SurgiMend PRS

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Italy
  • Veneto
    • Verona, Veneto, Italy, 37122
      • AULSS9 Scaligera
• Switzerland
  • Viganello, Switzerland
    • Ospedale Regionale di Lugano; Sede Ospedale Italiano
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust
  • Manchester, United Kingdom
    • North Manchester General Hospital
  • North West
    • London, North West, United Kingdom, NW3 2GQ
      • Royal Free Hospital
  • Yorkshire
    • Sheffield, Yorkshire, United Kingdom, S10 2JF
      • Royal Hallamshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of SurgiMend	The primary endpoint of this study is the proportion of patients who did not require additional surgical interventions at or associated with the site of the original reconstruction within 12 months after SurgiMend® PRS or SurgiMend® PRS Meshed implantation.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of SurgiMend	The secondary endpoint of this study is the occurrence of relevant (S)AEs within 12 months of SurgiMend® PRS or SurgiMend® PRS Meshed implantation.	24 months

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Adam Young, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: breast reconstruction
• Other Study ID Numbers: T-SUPORT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No