The SurgiMend PRS Retrospective Study

NCT05182177 | Completed

• 1 other identifier: T-SUPORT-001
• Study Type: observational
• Target: 84
• Locations: 3 countries
• Sites: 6

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.

Conditions

Reconstructive Surgical Procedures

Keywords

breast reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of SurgiMend

  24 months

Interventions

SurgiMend PRS DEVICE

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.

Also known as: SurgiMend PRS Meshed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Subject underwent mastectomy (index surgery) at a minimum of 24 months prior to study initiation at site

You may not qualify if:

• 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)

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (6)

AULSS9 Scaligera

Verona, Veneto, 37122, Italy

Location

Ospedale Regionale di Lugano; Sede Ospedale Italiano

Viganello, Switzerland

Location

Royal Free Hospital

London, North West, NW3 2GQ, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, Yorkshire, S10 2JF, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

North Manchester General Hospital

Manchester, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: January 31, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

GB (4); IT (1); CH (1)