The SurgiMend PRS Retrospective Study

Reconstructive Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05182177
• Other study ID #: T-SUPORT-001
• Status: Recruiting
• Start date: January 31, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Integra LifeSciences Corporation
• Contact: Andrew Tummon
• Phone: 609-529-5899
• Email: andrew.tummon[@]integralife.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Reconstructive Surgical Procedures

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	AULSS9 Scaligera	Verona	Veneto
Switzerland	Clinique des Grangettes	Geneva
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Royal Free Hospital	London	North West
United Kingdom	North Manchester General Hospital	Manchester
United Kingdom	Royal Hallamshire Hospital	Sheffield	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Countries where clinical trial is conducted

Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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