Mesh Use in Two-Stage Breast Reconstruction

Recruiting at 6 trial locations

Overseen By Bowen Ding

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Tianjin Medical University Cancer Institute and Hospital

Disqualifiers: Metastasis, Radiation, Inflammatory cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 1 year

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for breast reconstruction using TiLOOP Bra mesh. The goal is to determine if the mesh reduces complications and enhances the appearance of the reconstructed breast compared to traditional methods. Participants will receive breast reconstruction either with or without the mesh, enabling researchers to compare outcomes. Individuals diagnosed with breast cancer and planning to undergo breast reconstruction may be suitable candidates, particularly if they have not received radiation therapy to the breast or chest area. As an unphased trial, this study provides a unique opportunity to contribute to innovative research in breast reconstruction techniques.

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 prior data suggests that TiLOOP Bra mesh is safe for breast reconstruction?

Research shows that TiLOOP Bra mesh is generally safe for breast reconstruction. Coated with titanium, this mesh has proven effective and safe in the short term. It is used in immediate breast reconstruction and reportedly has a good safety record compared to other meshes, meaning it causes few post-surgery issues. Although this study is the first to focus on TiLOOP Bra mesh in a specific type of breast reconstruction, earlier research suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach to breast reconstruction, which typically involves using tissue expanders placed sub-pectorally and covered by muscle or fascia, the TiLOOP Bra mesh offers a unique method. This mesh is used to support the tissue expander-implant reconstruction, potentially providing more stability and better aesthetic outcomes. Researchers are excited about TiLOOP Bra mesh because it might reduce surgery time, enhance recovery, and improve the overall cosmetic results compared to traditional methods.

What evidence suggests that TiLOOP Bra mesh is effective for breast reconstruction?

Research shows that TiLOOP Bra mesh works well for breast reconstruction. In this trial, some participants will undergo breast reconstruction with TiLOOP Bra mesh, which studies have found safe and useful for immediate breast reconstruction. The titanium covering on this mesh helps support the breast implant. Patients who used TiLOOP Bra mesh reported good results, including better implant position and appearance. Early findings suggest it might lower the risk of complications like capsular contraction, where scar tissue hardens around the implant. Overall, the mesh seems promising for improving breast reconstruction outcomes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TiLOOP Bra mesh

Trial Overview 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.

How Is the Trial Designed?

Group I: Breast Reconstruction with breast mesh Experimental Treatment 1 Intervention

The tissue expander-implant reconstruction with TiLoop Bra mesh.

Group II: Breast Reconstruction without breast mesh Active Control 1 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 for the following indications:

Approved in European Union as TiLOOP Bra for:

• Breast reconstruction
• Breast augmentation

Who Is Running the Clinical Trial?

Tianjin Medical University Cancer Institute and Hospital

Lead Sponsor

Trials

415

Recruited

284,000+

Published Research Related to This Trial

The study identified a rice mutant (sprl1) with distinct leaf phenotypes caused by a mutation in the OsPPO1 gene, which is crucial for chloroplast function and affects the plant's response to light and temperature.

Transgenic rice plants that overexpress the OsPPO1 gene showed resistance to diphenyl ether-type herbicides without negatively impacting growth or grain yield, suggesting its potential for engineering herbicide resistance in rice crops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mutation of Protoporphyrinogen IX Oxidase Gene Causes Spotted and Rolled Leaf and Its Overexpression Generates Herbicide Resistance in Rice. Liu, X., Deng, XJ., Li, CY., et al.[2022]

PCL nanocapsules loaded with atrazine showed enhanced herbicidal activity against mustard plants compared to traditional atrazine formulations, effectively inhibiting growth and photosynthesis at a lower dosage.

The use of these nanocapsules allows for a ten-fold dilution of atrazine without losing effectiveness, suggesting a potential for reduced environmental impact while maintaining efficacy in weed control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nanoencapsulation Enhances the Post-Emergence Herbicidal Activity of Atrazine against Mustard Plants. Oliveira, HC., Stolf-Moreira, R., Martinez, CB., et al.[2023]

The use of TiLoop-BRA mesh for lower pole coverage in immediate breast reconstruction has significantly reduced overall complication rates compared to previous methods, with complete loss of implants at only 5.88%.

In a study of 103 breast reconstructions performed between July 2018 and April 2019, complications such as capsular contracture and painful syndrome were also notably lower, indicating improved safety and efficacy of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TiLoop Bra Assisted Breast Reconstruction - Our Experience. Krivorotko, PV., Pesotsky, RS., Zernov, KY., et al.[2021]

The use of the titanium-coated polypropylene mesh TiLOOP® Bra in breast reconstruction showed acceptable complication rates, with minor issues like hematoma and seroma that could be treated conservatively, while major complications like skin infections required surgical intervention.

Skin infections and necrosis were linked to a higher risk of needing mesh removal and implant explantation, but overall, the mesh was well-incorporated into surrounding tissue, suggesting it can be safely used in prosthesis-based breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A short follow-up of prosthesis-based breast reconstruction using TiLOOP® Bra surgical mesh. Chen, WX., Cheng, L., Xu, LY., et al.[2022]

Skin sparing and nipple areola complex sparing subcutaneous mastectomies are safe surgical options for breast cancer treatment, allowing for effective cancer removal while preserving more breast tissue.

The use of titanium coated polypropylene mesh (Tiloop Bra) in implant-based breast reconstruction has shown excellent cosmetic results, indicating it can be a valuable support material in post-mastectomy reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin-Areola, Nipple Sparing, and Subcutaneous Mastectomy and Immediate Implant-Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh. Özel, L., Kara, VM., Sunamak, O., et al.[2020]

The use of TiLOOP(®) Bra mesh in breast reconstruction can lead to the formation of granulomas, which may complicate the diagnosis of local cancer recurrence, as seen in a case involving a patient with high-grade ductal carcinoma in situ.

A new surgical technique is proposed to prevent granuloma formation, and it is emphasized that any nodules that appear post-surgery should be thoroughly investigated rather than assumed to be benign granulomatous reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can titanium mesh influence local recurrence management after implant-based breast reconstruction? Riggio, E., Chifu, C., Martelli, G., et al.[2020]

In a study involving 18 women undergoing immediate breast reconstruction (IBR) with prepectoral implant placement, the use of TiLoop® Bra titanium-coated polypropylene mesh significantly reduced the surgical time for implant positioning to an average of four minutes.

The procedure demonstrated a low complication rate, with only three patients experiencing issues that resolved within four weeks, indicating a reduced risk of infection and bacterial contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prepectoral breast reconstruction with TiLoop® Bra Pocket: a single center prospective study. Lo Torto, F., Marcasciano, M., Kaciulyte, J., et al.[2021]

Tiafenacil is a new herbicide that inhibits protoporphyrinogen IX oxidase (PPO) with a half-maximal inhibitory concentration (IC50) of 22 to 28 nM, making it as effective as other known herbicides like butafenacil and saflufenacil.

This herbicide is non-selective, affecting both dicot and monocot plants, and causes harmful effects in treated plants, such as increased malondialdehyde levels and decreased chlorophyll fluorescence, indicating its potential for widespread use against various weeds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical and physiological mode of action of tiafenacil, a new protoporphyrinogen IX oxidase-inhibiting herbicide. Park, J., Ahn, YO., Nam, JW., et al.[2019]

Transgenic rice plants expressing Bacillus subtilis Protox showed increased enzyme activity and enhanced photosynthetic efficiency compared to wild-type plants, indicating a successful modification of the porphyrin pathway.

Both cytoplasm-expressed and plastid-targeted transgenic plants produced higher levels of key porphyrin biosynthesis intermediates, which suggests that these modifications can improve plant resilience to herbicides and potentially enhance growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Either soluble or plastidic expression of recombinant protoporphyrinogen oxidase modulates tetrapyrrole biosynthesis and photosynthetic efficiency in transgenic rice. Jung, S., Chung, JS., Jang, SM., et al.[2015]

The Val311Met point mutation in Bacillus subtilis protoporphyrinogen oxidase does not significantly alter the enzyme's overall kinetic properties compared to the wild type, indicating that the mutation does not drastically affect its function.

However, the Val311Met mutant shows increased sensitivity to the herbicide oxyfluorfen, with a 1.5 times higher inhibition constant, suggesting that this mutation may not play a crucial role in resistance to diphenyl ether herbicides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A point mutation of valine-311 to methionine in Bacillus subtilis protoporphyrinogen oxidase does not greatly increase resistance to the diphenyl ether herbicide oxyfluorfen. Jeong, E., Houn, T., Kuk, Y., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4197328/

TiLoop® Bra mesh used for immediate breast reconstruction Titanium-coated polypropylene meshes, as a tool for immediate definitive implant breast reconstruction, resulted as safe and effective in a short-term analysis.

2. ecancer.org ecancer.org/en/journal/article/796-novel-devices-for-implant-based-breast-reconstruction-is-the-use-of-meshes-to-support-the-lower-pole-justified-in-terms-of-benefits-a-review-of-the-evidence

Novel devices for implant-based breast reconstruction TiLOOP Bra (pfm medical titanium, Nuremberg, Germany) is a non-absorbable, titanium coated polypropylene mesh (TCPM), which has been approved ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03868514?tab=table

NCT03868514 | Post Market Clinical Follow Up to "Patient ... The objective of the clinical Investigation is to establish the efficacy and safety of the TiLOOP® Bra Pocket. The Investigation will be performed in ten ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34635454/

Prepectoral implant-based breast reconstruction with ... Results: A total of 63 breasts (43 patients) were reconstructed using the TiLOOP® Bra Pocket between 2018 and 2020, 57 were immediate reconstructions. The ...

5. pfmmedical.com pfmmedical.com/knowledge/studies/study-on-tiloop-bra-pocket/

Study on TiLOOP Bra Pocket | pfm medical gmbh Observational study on TiLOOP® Bra. A national, multicentre observational study on Patient Reported Outcome in breast reconstruction after mastectomy with ...

6. pfmmedical.co.uk pfmmedical.co.uk/products/mesh-implants-for-breast-surgery/tiloopr-bra/

TiLOOP® Bra Results: TiLOOP® Bra is safe, and suitable for implant-based breast reconstruction ... 16g/m2, Extralight, Titanized Polypropylene, Small. 6000637, 16g/m2 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38353413/

Application of TiLOOP bra in implant-based breast ... TiLOOP bra in IBBR has a favored safety profile over other meshes, which significantly reduced postoperative complication risk and did not affect patient ...