Mesh Use in Two-Stage Breast Reconstruction
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Disqualifiers: Metastasis, Radiation, Inflammatory cancer, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment TiLOOP Bra mesh in two-stage breast reconstruction?
Research shows that using TiLOOP Bra mesh in breast reconstruction can lead to lower complication rates, such as reduced implant loss and fewer cases of painful syndromes. Additionally, it provides good support and coverage for implants, which can result in better cosmetic outcomes.
12345What makes the TiLOOP Bra mesh treatment unique in two-stage breast reconstruction?
The TiLOOP Bra mesh is unique in two-stage breast reconstruction because it is a specialized surgical mesh designed to support and shape the breast tissue during reconstruction, offering a novel approach compared to traditional methods that may not use such supportive materials.
678910Eligibility Criteria
This trial is for breast cancer patients with a BMI under 35, no distant metastasis, good performance status (KPS > 80), minimal breast sagging, and over 18 years old. They must have normal organ function and mental health. Excluded are those with mental illness, pregnant or breastfeeding women, past chest radiation, stage IV cancer or severe allergies.Inclusion Criteria
I have been diagnosed with breast cancer.
You weigh less than 35 kilograms for every square meter of your height.
My cancer has not spread to distant parts of my body.
+5 more
Exclusion Criteria
My breast cancer is inflammatory or at stage IV.
You have a history of severe allergies or specific health conditions.
You have a history of using drugs or drinking alcohol excessively.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo tissue expander-implant reconstruction with or without TiLOOP Bra mesh
up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment, including complication rates and aesthetic outcomes
up to 24 months
Participant Groups
The study tests the effectiveness of TiLOOP Bra mesh in two-stage expander-implant breast reconstruction compared to standard sub-pectoral methods. It aims to see if this mesh can reduce complications like capsular contraction and improve aesthetic outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Breast Reconstruction with breast meshExperimental Treatment1 Intervention
The tissue expander-implant reconstruction with TiLoop Bra mesh.
Group II: Breast Reconstruction without breast meshActive Control1 Intervention
The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
TiLOOP Bra mesh is already approved in European Union, Australia for the following indications:
🇪🇺 Approved in European Union as TiLOOP Bra for:
- Breast reconstruction
- Breast augmentation
🇦🇺 Approved in Australia as TiLOOP Bra for:
- Breast reconstruction
- Breast augmentation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
Tianjin Medical University Cancer Institute and HospitalLead Sponsor
References
Prepectoral breast reconstruction with TiLoop® Bra Pocket: a single center prospective study. [2021]In the last decades, immediate breast reconstruction (IBR) raised in frequency, and prepectoral positioning of the implant is becoming the trend nowadays. The aim of this paper is to describe our case series in IBR with prepectoral implant placement and complete coverage of it with the TiLoop® Bra titanium-coated polypropylene mesh (TCPM), pre-shaped as a pocket.
TiLoop Bra Assisted Breast Reconstruction - Our Experience. [2021]Additional covering of the lower pole with allomaterial or its synthetic analogues during immediate breast reconstruction is being perfomed at the N.N. Petrov National Medical Research Oncology Center, Ministry of Healthcare of Russian Federation for last 7 years. Initially, epidermal flap was the only option for lower pole coverage, later ADM was used as part of clinical approbation. Average complication rate ranges from 20-35% due to blood circulatory (supply) disorders. Since 2018, a titanized mesh (TiLoop Bra) been used as a additional coverage of the lower pole. Methods: From July 2018 to April 2019, 103 breast reconstructions were performed using TiLoop-BRA mesh. All operations were performed due to malignant tumors of breast, of which in 94 operations were performed for unilateral breast carcinoma, 9 for bilateral breast carcinoma.74 patients received neoadjuvant therapy, 31 received adjuvant therapy, 17 patients required radiation therapy. Results: Overall complications rates significally decreased. Complete loss of breast implant and mesh endoprosthesis 5.88%, Capsular contracture 17.65 %, Only mesh removal due to painful syndrome 5.88%,* Red breast * syndrome (by analogy with ADM) 5.88%.
A short follow-up of prosthesis-based breast reconstruction using TiLOOP® Bra surgical mesh. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">A new approach for prosthesis-based breast reconstruction is the use of a titanium-coated polypropylene mesh TiLOOP® Bra. However, the safety and outcomes are currently unclear in Chinese breast cancer patients.
Skin-Areola, Nipple Sparing, and Subcutaneous Mastectomy and Immediate Implant-Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh. [2020]Skin sparing and nipple areola complex sparing subcutaneous mastectomies are both oncologically safe surgical procedures. Although autologuous breast reconstruction has been considered as a standard means of surgical approach, excellent cosmetic results have been obtained by implant based breast reconstruction. In this report, we present the result of titanium coated polypropylene mesh (Tiloop Bra; Pfm Medical, Cologne, Germany), an ultimate support material utilized in the reconstruction of a patient with breast cancer.
Can titanium mesh influence local recurrence management after implant-based breast reconstruction? [2020]TiLOOP(®) Bra is a permanent titanium-coated polypropylene mesh currently used in post-mastectomy breast reconstruction with implants. This mesh is generally presented as inducing low-grade inflammatory reactions, but only few reports focused on its possible side effects. In the case described here, the use of the mesh led to minor clinical problems that needed to be clinically and surgically managed at the same time as a local relapse.
Biochemical and physiological mode of action of tiafenacil, a new protoporphyrinogen IX oxidase-inhibiting herbicide. [2019]We conducted biochemical and physiological experiments to investigate the mode of action of tiafenacil (Terrad'or™), a new protoporphyrinogen IX oxidase (PPO)-inhibiting pyrimidinedione herbicide. Analysis of the half-maximal inhibitory concentration (IC50) against recombinant PPO enzymes from various plant species, including amaranth (Amaranthus tuberculatus), soybean (Glycine max), arabidopsis (Arabidopsis thaliana), and rapeseed (Brassica napus), showed that tiafenacil had an IC50 of 22 to 28 nM, similar to the pyrimidinedione herbicides butafenacil and saflufenacil and the N-phenylphthalimide herbicide flumioxazin. By contrast, tiafenacil exhibited 3- to 134-fold lower IC50 values than the diphenyl ether herbicides fomesafen, oxyfluorfen, and acifluorfen. Tiafenacil is non-selective and is herbicidal to both dicots and monocots, such as the weeds velvetleaf (Abutilon theophrasti), amaranth, and barnyardgrass (Echinochloa crus-galli) as well as the crops soybean, rapeseed, rice (Oryza sativa), and maize (Zea mays) at concentrations ranging from 1 to 50 μM. Treatment of plant tissue with tiafenacil in darkness resulted in the accumulation of protoporphyrin IX. Subsequent exposure to light increased the content of malondialdehyde and significantly decreased the Fv/Fm values of chlorophyll fluorescence. The results suggest that tiafenacil is a new PPO-inhibiting pyrimidinedione herbicide.
Mutation of Protoporphyrinogen IX Oxidase Gene Causes Spotted and Rolled Leaf and Its Overexpression Generates Herbicide Resistance in Rice. [2022]Protoporphyrinogen IX (Protogen IX) oxidase (PPO) catalyzes the oxidation of Protogen IX to Proto IX. PPO is also the target site for diphenyl ether-type herbicides. In plants, there are two PPO encoding genes, PPO1 and PPO2. To date, no PPO gene or mutant has been characterized in monocotyledonous plants. In this study, we isolated a spotted and rolled leaf (sprl1) mutant in rice (Oryza sativa). The spotted leaf phenotype was sensitive to high light intensity and low temperature, but the rolled leaf phenotype was insensitive. We confirmed that the sprl1 phenotypes were caused by a single nucleotide substitution in the OsPPO1 (LOC_Os01g18320) gene. This gene is constitutively expressed, and its encoded product is localized to the chloroplast. The sprl1 mutant accumulated excess Proto(gen) IX and reactive oxygen species (ROS), resulting in necrotic lesions. The expressions of 26 genes associated with tetrapyrrole biosynthesis, photosynthesis, ROS accumulation, and rolled leaf were significantly altered in sprl1, demonstrating that these expression changes were coincident with the mutant phenotypes. Importantly, OsPPO1-overexpression transgenic plants were resistant to the herbicides oxyfluorfen and acifluorfen under field conditions, while having no distinct influence on plant growth and grain yield. These finding indicate that the OsPPO1 gene has the potential to engineer herbicide resistance in rice.
A point mutation of valine-311 to methionine in Bacillus subtilis protoporphyrinogen oxidase does not greatly increase resistance to the diphenyl ether herbicide oxyfluorfen. [2019]In an effort to asses the effect of Val311Met point mutation of Bacillus subtilis protoporphyrinogen oxidase on the resistance to diphenyl ether herbicides, a Val311Met point mutant of B. subtilis protoporphyrinogen oxidase was prepared, heterologously expressed in Escherichia coli, and the purified recombinant Val311Met mutant protoporphyrinogen oxidase was kinetically characterized. The mutant protoporphyrinogen oxidase showed very similar kinetic patterns to wild type protoporphyrinogen oxidase, with slightly decreased activity dependent on pH and the concentrations of NaCl, Tween 20, and imidazole. When oxyfluorfen was used as a competitive inhibitor, the Val311Met mutant protoporphyrinogen oxidase showed an increased inhibition constant about 1.5 times that of wild type protoporphyrinogen oxidase. The marginal increase of the inhibition constant indicates that the Val311Met point mutation in B. subtilis protoporphyrinogen oxidase may not be an important determinant in the mechanism that protects protoporphyrinogen oxidase against diphenyl ether herbicides.
Nanoencapsulation Enhances the Post-Emergence Herbicidal Activity of Atrazine against Mustard Plants. [2023]Poly(epsilon-caprolactone) (PCL) nanocapsules have been recently developed as a modified release system for atrazine, an herbicide that can have harmful effects in the environment. Here, the post-emergence herbicidal activity of PCL nanocapsules containing atrazine was evaluated using mustard (Brassica juncea) as target plant species model. Characterization of atrazine-loaded PCL nanocapsules by nanoparticle tracking analysis indicated a concentration of 7.5 x 10(12) particles mL(-1) and an average size distribution of 240.7 nm. The treatment of mustard plants with nanocapsules carrying atrazine at 1 mg mL(-1) resulted in a decrease of net photosynthesis and PSII maximum quantum yield, and an increase of leaf lipid peroxidation, leading to shoot growth inhibition and the development of severe symptoms. Time course analysis until 72 h after treatments showed that nanoencapsulation of atrazine enhanced the herbicidal activity in comparison with a commercial atrazine formulation. In contrast to the commercial formulation, ten-fold dilution of the atrazine-containing nanocapsules did not compromise the herbicidal activity. No effects were observed when plants were treated with nanocapsules without herbicide compared to control leaves sprayed with water. Overall, these results demonstrated that atrazine-containing PCL nanocapsules provide very effective post-emergence herbicidal activity. More importantly, the use of nanoencapsulated atrazine enables the application of lower dosages of the herbicide, without any loss of efficiency, which could provide environmental benefits.
Either soluble or plastidic expression of recombinant protoporphyrinogen oxidase modulates tetrapyrrole biosynthesis and photosynthetic efficiency in transgenic rice. [2015]Protoporphyrinogen oxidase (Protox) is the last shared enzyme of the porphyrin pathway. As a continuation of our previous work in which the transgenic rice plants expressing the Bacillus subtilis Protox in the cytoplasm or the plastid showed resistance to diphenyl ether herbicide, this study was undertaken to identify the effects of tertapyrrole biosynthesis in these transgenic rice plants. The transgenic plants either targeted into plastids or expressed in cytoplasm showed higher Protox activity than wild-type plants did. Photosynthetic activity, measured as a quantum yield of photosystem II, was slightly higher in transgenic plants than in wild-type plants, but chlorophyll contents were not significantly different between transgenic and wild-type plants. As for porphyrin biosynthesis, both cytoplasm-expressed and plastid-targeted transgenic plants showed increased synthesis of aminolevulinic acid, Mg-Proto IX, and protoheme in comparison to wild-type plants whereas synthesis of protoporphyrin IX was similar for wild-type and transgenic plants. These results indicate that either cytoplasm or plastid expression of B. subtilis Protox in rice can upregulate the porphyrin pathway leading to increase in photosynthetic efficiency in plants.