Glubran ® 2 Breast Surgery

Glubran® 2 in Breast Surgery

SURGICAL SPECIALIZATION

Seal. Protect. Heal.

Advanced Sealing and Hemostatic Control in Breast Surgery

Glubran® 2 is a sealant, adhesive, and hemostatic agent with bacteriostatic properties, designed for breast surgery. Its spray application enables:

  • Sealing of transected lymphatic vessels
  • Reduction of seroma and lymphatic leakage risk
  • Promotion of optimal aesthetic wound closure
  • Control of post-dissection oozing bleeding

Key advantage: the sealing layer is resistant and permanent, and more effective than conventional fibrin glues.

Indications of Use

Glubran® 2 is indicated for:

  • Closure and sealing of transected lymphatic vessels in mastectomy or quadrantectomy procedures
  • Prevention of seroma formation and reduction of lymphatic leakage
  • Hemostasis of oozing bleeding after tissue dissection and flap elevation
  • Suture replacement for aesthetic surgical wound closure
The spray application of Glubran® 2 creates a durable sealing layer that prevents seroma formation caused by tissue exudate and lymph leakage from transected lymphatic channels. Its synthetic nature and strong adhesiveness ensure a long-lasting and permanent effect, superior to commonly used fibrin glues. ¹⁻⁶

Clinical Evidence

Clinical studies have demonstrated the efficacy and safety of Glubran® 2:

Seroma reduction

Randomized prospective study (128 patients):

In patients undergoing total or partial mastectomy with lymph node dissection, spray application of Glubran® 2 led to a significant reduction in drained seroma volume, shorter postoperative drainage duration, and a lower rate of postoperative complications.1

PARAMETRI GLUBRAN® 2 CONTROLLO P
Pazienti (n) 64 64 -
Età (anni) 61.67 ± 10.36 61.34 ± 10.86 0.994
Body mass index (kg/m²) 28.50 ± 3.44 31.90 ± 4.61 0.000
Massa tumore (g) 541.41 ± 358.57 473.14 ± 380.53 0.037
Tempo operatorio (min) 108.56 ± 37.47 124.89 ± 44.79 0.042
Dimensioni del (mm) 1.13 ± 0.52 1.01 ± 0.50 0.097
Linfonodi rimossi (n) 20.68 ± 5.64 14.67 ± 3.95 0.000
Linfonodi infiltrati (n) 4.29 ± 2.38 3.24 ± 2.78 0.000
Permanenza del 2.51 ± 0.89 3.63 ± 1.62 0.000
Seroma: drenato (ml) 155.77 ± 103.35 457.81 ± 435.51 0.000
Seroma: aspirato (ml) 25.46 ± 27.14 94.69 ± 109.26 0.000

Reduction of postoperative infections

Observational study (41 patients):

A comparison between Glubran® 2, Tisseel, and no treatment showed a significant reduction in axillary drain duration and postoperative infections, confirming the clinical benefit of Glubran® 2 in seroma management.5

PARAMETRI SOLO DRENAGGIO TISSEEL GLUBRAN® 2 P
Pazienti (N=41) N = 17 N = 7 N = 17 P<0.05
Permanenza del drenaggio 14.1 ± 8.7 11.4 ± 7.9 7.4 ± 3.2 0.02
Incidenza d'infezioni 23 57 6 0.02
Incidenza di seromi 11.8 14 6 0.76

Ongoing RCTs (220 patients):

Preliminary data confirm that the use of Glubran® 2 significantly reduces axillary drain duration in patients undergoing axillary dissection associated with mastectomy or breast-conserving surgery.3-4

Dedicated Devices

To optimize the application of Glubran® 2 in breast surgery, dedicated spray applicators are available

DEVICE IMAGE DISTANCE FROM TISSUE SPRY DIAMETER INDICATED USE BREAST SURGERY
SHORT SPRAY DEVICE (G2-NBT SHORT) Short Spray Device 5–7 cm 4 cm On large areas in open surgery Sealing, Haemostasis
SHORT MINI SPRAY DEVICE (G2-NBT SM SHORT) Mini Spray Device 2–3 cm 1 cm On small areas in open surgery Sealing, Haemostasis
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Usage Protocol

  • Apply spray-applied Glubran® 2 to the surgical site at an appropriate distance (see device guidelines).
  • Ensure uniform coverage of exposed surfaces to maximize the sealing effect and prevent seroma formation.
  • Monitor the postoperative site and drainage according to standard hospital protocols.

Bibliography

1 Vasileiadou K, Kosmidis C, Anthimidis G, Miliaras S, Kostopoulos I, Fahantidis E. Cyanoacrylate Adhesive Reduces Seroma Production After Modified Radical Mastectomy or Quadrantectomy With Lymph Node Dissection - A Prospective Randomized Clinical Trial. Clin Breast Cancer. 2017 Dec;17(8):595-600

2 Foroni F. General surgery. Glubran® 2 to reduce lymphorrhoea in breast surgery. Symposium "Can leaks be prevented and treated using a strong synthetic spray sealant?" Proceedings XXVIII SPIGC National Congress Varese, 22-24 March 2017; 9. Ed. Medimay

3 Esposito E. The application of nebulized Glubran® 2 in breast surgery. Preliminary results of the Glubreast trial. XLII SICO Congress: Influencing Oncology through qualified Surgery. Proceedings. Cagliari Sept 2019: 9-10. Ed. Medimay

4 Esposito, E., Siani C., Fucito A., Rinaldo M., Di Giacomo R. (2019). A randomised controlled trial to validate the efficacy of a cianoacrylate based sealing glue to reduce axillary seroma. GLUBREAST TRIAL. 10.13140/RG.2.2.35733.78569.

5 De Luca A, Tripodi D, Frusone F, Leonardi B, Cerbelli B, Botticelli A, Vergine M, D'Andrea V, Pironi D, Sorrenti S, Amabile MI. Retrospective Evaluation of the Effectiveness of a Synthetic Glue and a Fibrin-Based Sealant for the Prevention of Seroma Following Axillary Dissection in Breast Cancer Patients. Front Oncol. 2020 Jul 17;10:1061. doi: 10.3389/fonc.2020.01061. PMID: 32766138; PMCID: PMC7379884.

6 Tripodi D, Frusone F, Leonardi B, Melcarne R, Borcea MC, Aceti V, Amabile MI, Vergine M, Monti M, De Luca A. Metodi e materiali per la prevenzione del sieroma dopo dissezione ascellare in pazienti affette da carcinoma mammario publication date Nov 6, 2019 publication description AIS: Attualità in Senologia Firenze 6-8 novembre 2019