Mesh Use in Two-Stage Breast Reconstruction

Recruiting at 5 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

Trial Summary

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. ^{1 2 3 4 5}

What 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. ^{6 7 8 9 10}

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.

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Prepectoral breast reconstruction with TiLoop® Bra Pocket: a single center prospective study. [2021]

2. Romania pubmed.ncbi.nlm.nih.gov

TiLoop Bra Assisted Breast Reconstruction - Our Experience. [2021]

3. India pubmed.ncbi.nlm.nih.gov

A short follow-up of prosthesis-based breast reconstruction using TiLOOP® Bra surgical mesh. [2022]

4. Turkey pubmed.ncbi.nlm.nih.gov

Skin-Areola, Nipple Sparing, and Subcutaneous Mastectomy and Immediate Implant-Based Breast Reconstruction Using a Titanium-Coated Polypropylene Mesh. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Can titanium mesh influence local recurrence management after implant-based breast reconstruction? [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Biochemical and physiological mode of action of tiafenacil, a new protoporphyrinogen IX oxidase-inhibiting herbicide. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Mutation of Protoporphyrinogen IX Oxidase Gene Causes Spotted and Rolled Leaf and Its Overexpression Generates Herbicide Resistance in Rice. [2022]

8. United States 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. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Nanoencapsulation Enhances the Post-Emergence Herbicidal Activity of Atrazine against Mustard Plants. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Either soluble or plastidic expression of recombinant protoporphyrinogen oxidase modulates tetrapyrrole biosynthesis and photosynthetic efficiency in transgenic rice. [2015]