Patient and Surgical Related Risk Factors for Complications
Conditions
Keywords
breast reconstruction, mesh, implant reconstruction, acellular dermal matrix, titanized polypropylene mesh, TiLOOP Bra, TiLOOP, implant based breast reconstruction
Brief summary
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM). These TCPM have a good biocompatibility and can be used in a similar way as ADM. This study addresses indications, limitations and complications of TCPM in implant based breast reconstruction.
Detailed description
An alternative to ADM is the usage of a titanium-coated polypropylene mesh (TCPM=TiLOOP(R) Bra), which is approved for breast reconstruction in Europe. The surgical approach is identical in comparison to ADM reconstruction and has been described previously. This titanium coated lightweight mesh consists of a monofilament structure and was initially invented for hernia repair which has a good biocompatibility. Observed cellular reactions like proliferation and apoptosis were at the lowest level when using this lightweight TCPM compared to not titanium-coated meshes (pure polypropylene (PP), pure lightweight PP mesh or PP mesh incorporating resorbable polyglactic acid). Histopathological analysis of an intraoperative sample of a TCPM after expander/implant BR demonstrated a well incorporated mesh with only weak inflammatory reactions. Preliminary data of in-vitro investigations at the investigators institute confirms the good biocompatibility of this TCPM in distinctive breast tissues (fibroblasts, fat cells, muscle cells) Although meshes are used in a large scale there are no sufficient clinical data regarding safety and outcome. In this multicenter study the investigators are able to investigate a large cohort of patients undergoing implant based breast reconstruction using a TCPM.
Interventions
None listed
Sponsors
University of Rostock
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for immediate or secondary implant based breast reconstruction
Exclusion criteria
* age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Received TiLOOP Mesh Reconstruction | 1 month | Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | 2 years | Secondary study outcome was the prevalence of complications. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TiLOOP Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included. | 207 |
| Total | 207 |
Baseline characteristics
| Characteristic | TiLOOP |
|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 11.6 |
| Gender Female | 207 Participants |
| Gender Male | 0 Participants |
| Region of Enrollment Germany | 207 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Participants Who Received TiLOOP Mesh Reconstruction
Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TiLOOP | Participants Who Received TiLOOP Mesh Reconstruction | 207 Patients with TiLOOP mesh reconstruction |
Secondary
Complication Rate
Secondary study outcome was the prevalence of complications.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TiLOOP | Complication Rate | Major Complications | 13.4 percentage of participants |
| TiLOOP | Complication Rate | Minor Complications | 15.6 percentage of participants |