Reconstructive Surgical ProceduresNCT05182177
The SurgiMend PRS Retrospective Study
An observational study of Reconstructive Surgical Procedures, run by Integra LifeSciences Corporation at 6 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reconstructive Surgical Procedures
- What is being tested?
- SurgiMend PRS
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 31 Jan 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United Kingdom4 sites
Royal Free Hospital
London, North West, NW3 2GQ
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
North Manchester General Hospital
Manchester
Royal Hallamshire Hospital
Sheffield, Yorkshire, S10 2JF
Switzerland1 site
Ospedale Regionale di Lugano; Sede Ospedale Italiano
Viganello
About this study
Official title: 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.
- Conditions
- Reconstructive Surgical Procedures
- Being tested
- SurgiMend PRS
- Keywords
- breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgiMend PRSDevice
Also called SurgiMend PRS Meshed
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start31 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182177
- Sponsor's protocol ID
- T-SUPORT-001
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Retrospective Review of Implant-Based Post Mastectomy Breast Reconstruction Utilizing SurgiMend® Collagen Matrix in Prepectoral and Submuscular Surgical Approaches
- ClinicalTrials.gov ID
- NCT05182177
- Acronym / sponsor ID
- T-SUPORT-001
- Conditions
- Reconstructive Surgical Procedures
- Keywords
- breast reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgiMend PRSAlso: SurgiMend PRS MeshedSurgiMend® 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. | Device | – |
Primary outcome
Performance of SurgiMend
Time frame: 24 months
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.
1 secondary outcome
Safety of SurgiMend
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reconstructive Surgical Procedures, run by Integra LifeSciences Corporation at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of SurgiMend (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.