Clinical trial NCT06511167: Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
Official title: National, Prospective, Multicentre Post Market Surveillance Study on "Patient Reported Outcome" of Implant Based Primary or Secondary Reconstructive Breast Surgery After Mastectomy Using the Complete Resorbable Synthetic TIGR® Matrix
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Implant Based Breast Reconstruction
Keywords: TIGR® Matrix
Quality of Life
Lead sponsor: AWOgyn
Sponsor class: OTHER
Collaborators: name: Esculape GmbH
First posted: 2024-07-19
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who will undergo breast prepectoral implant-based breast reconstructive surgery

Brief summary: The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.

Detailed description: This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.

Eligibility criteria: Inclusion Criteria:

* Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation
* The health of women must comply with ECOG performance status 0-2
* The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment
* Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
* Patient information has been handed out and subject signed informed consent
* Participant has attained full age of 18 years

Exclusion Criteria:

* Pregnancy or breast-feeding patients
* Known intolerance to the material, mesh-implants under investigation
* Metastatic breast cancer (with a life expectancy \< 5 years)
* Medicinal dis-regulated diabetes
* Inadequate bone marrow function with neutrophil granulocytes\<1500 and blood plates \< 100.000/µl
* Lack or withdrawn of written patients informed consent
* Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol
* Participant is institutionalized by court or official order (MPDG §27)
* Participation in another surgical clinical investigation that influence the surgical technique or outcome.

Primary outcomes:
measure: Quality of Life 12 months after surgery (BREAST-Q)
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Quality of Life 6, 24, 36 months after surgery (BREAST-Q)
timeFrame: 6, 24, 36 months after surgery
measure: Complication rate
timeFrame: minimum of 3 years and a maximum of 5 years after surgery
measure: Complication rate of specific complications
timeFrame: minimum of 3 years and a maximum of 5 years after surgery
measure: Days with drain(s)
timeFrame: during hospital stay after surgery
measure: Days of hospital stay
timeFrame: surgery to discharge from hospital
measure: Cosmetic outcome
timeFrame: 6, 12, 24 ,36 month after surgery
measure: Rate of unplanned conversion operations
timeFrame: minimum of 3 years and a maximum of 5 years after surgery
Other outcomes:
Locations:
city: Weinheim
country: Germany
facility: GRN-Klinik Weinheim
state: Baden-Württemberg
city: München
country: Germany
facility: Klinik und Poliklinik für Frauenheilkunde Technische Universität München
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Agaplesion Markus Krankenhaus Frankfurt
state: Hessen
city: Wesel
country: Germany
facility: Evangelisches Krankenhaus Wesel
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Study officials:
affiliation: AWOgyn
name: Marc Thill, Prof.
role: STUDY_CHAIR
References: