Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery

NCT06462066 | Completed

• 1 other identifier: DGDMF/P/I.5.i.m.2/2019/1321
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in laparoscopic and robotic hernia surgery to obtain the indication and upgrade the medical device Glubran® Tiss 2 to class IIb.Cyanoacrylate is the generic name of a group of fast-acting adhesives such as ethyl-2-cyanoacrylate, n-butyl cyanoacrylate, 2-octy1 cyanoacrylate sold under various trade names and blend. Cyanoacrylate is a liquid acrylate monomer that polymerizes exothermically in the presence of water, especially with hydroxide ions, joining the bonded surfaces in 4-5 s and reaching the final stage in 60-90 s . It bonds body tissue excellently and shows bacteriostatic effects . The film of glue is eliminated by hydrolytic breakdown, a process whose duration varies according to tissue type and quantity . In contrast to most cyanoacrylate glues used only for external applications as skin wound closure, Glubran® 2 is a modified n-butyl-cyanoacrylate (Glubran® 2 - N-Butyl 2 Cyanoaciylate \[NBCA\]+ Methacryloxysulfolane \[MS\]), class III medical device, CE-certified for both external and internal use . Glubran® 2 effectiveness in repairing hernias with less post-operative pain, less complications, less hernia recurrences and a greater cost-effectiveness is largely documented . Other cyanoacrylate-based glues are authorized to fix hernia meshes, i.e.: Histoacryl (pure NBCA; classified as class IIb medical device), Liquibond FIX8 (pure NBCA; classified as class III medical device) and Ifabond (n-hexyl-cyanoacrylate; classified as class III medical device). Others are authorized to be used for specific internal indication like Omnex (2-Octyl-CyanoAcrylate \[OCA\] + Butyl-Lactoyl-Cyanoacrylate), which is indicated for use in vascular reconstructions. Sometimes, abroad, also some cyanoacrylate-based glues are applied for internal uses even if not authorized . The present prospective and randomized study was aimed at comparing the effectiveness and safety of another cyanoacrylate-based glue called Glubran® Tiss 2 (NBCA + OCA), classified as class IIa surgical medical device, CE-marked (under the European Union \[EU\] Directive 93/42 EEC), being already authorized for use as atraumatic fixation system: Glubran® 2. Both medical devices have previously demonstrated to be well-tolerated and safe. Glubran® 2 and Glubran® Tiss 2 were to be applied by Glutack®, a CE-marked medical device system for glue application in the surgical field. Glutack® is the related Glubran® 2/ Glubran® Tiss 2 applicator device for laparoscopic mesh fixation procedures was fabricated to offer a precise and controlled delivery of Glubran® glues . Glubran® Tiss 2 fulfils the requirements of EU Medical Device Regulation (MDR) 2017/745 (confirmation letter received by the relative Notified Body). The composition of Glubran® Tiss 2 is obtained by mixing two different monomers of cyanoacrylate (NBCA + OCA); this gives the product a better elasticity, while maintaining high levels of tensile strength. In fact, international scientific literature has shown that the common NBCA is the cyanoacrylate molecule with the greatest tensile strength (34.27 N), low elasticity, while OCA has a lower resistance (11.27 N) but has good elastic properties. Glubran® Tiss 2 glue has a tensile strength of 27.34 N and thanks to the presence of OCA, also excellent elasticity . Among its characteristics, this formulation has haemostatic, sealing, bacteriostatic and adhesive properties. Polymerization begins 1-2 seconds after application and completes within 60 seconds. The polymerization reaction generates a temperature of approximately 45°C, which is lower than that of pure cyanoacrylates . Glubran® Tiss 2, indicated also for use in paediatrics, is a sterile, ready for use, blended cyanacrylate adhesive to be used on the skin and mucosal tissues, which is approved as class IIa medical device, effective even in patients anticoagulated and with congenital coagulopathies .

Conditions

Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  A clinical examination will be conducted to evaluate recurrence. If there will be any suspicion of recurrence, an ultrasound, MRI or CT is performed according to hospital practice to distinguish true hernia recurrences from bulging. Technical success of glue fastening will be evaluated intra-operatively, the investigator will register whether mesh fixation system achieved technical success or not. Technical success is defined as successful hernia repair as intended.

  Verification of hernia recurrence at 1 day, 1 or 2 weeks, 3 months, 6 months

Secondary Outcomes (5)

• Clinical Safety:

  Verification of Clinical safety at 1 day, 1 or 2 weeks, 3 months, 6 months

• Chronic pain

  Verification of chronic pain at 3 months, 6 months

• Quality of the life

  Verification of QoL at 1 day, 1 or 2 weeks, 3 months, 6 months

• Cost effectiveness

  Verification of cost effectiveness at 1 day, 1 or 2 weeks, 3 months, 6 months

• Appropriateness

  Verification of Appropriateness at Intervention day during the procedure

Study Arms (2)

Glubran® Tiss

EXPERIMENTAL

The application of treatment will be performed by the Investigator that will be instructed for the application of Glutack/Glubran® Tiss 2 system. Glutack® is a user-friendly device for the atraumatic laparoscopic fixation of hernia mesh. Providing precise and consistent delivery of Glubran® Tiss 2/Glubran® 2 with every pull of the trigger, to minimize surgical complications and the potential pain associated with the use of tacks and staples.

Procedure: Experimental medical device

Glubran® 2

ACTIVE COMPARATOR

The application of treatment will be performed by the Investigator that will be instructed for the application of Glutack/Glubran® 2 system. Glutack® is a user-friendly device for the atraumatic laparoscopic fixation of hernia mesh. Providing precise and consistent delivery of Glubran® Tiss 2/Glubran® 2 with every pull of the trigger, to minimize surgical complications and the potential pain associated with the use of tacks and staples.

Procedure: Comparator medical device

Interventions

Experimental medical device PROCEDURE

Open the blister and pour the sterile single-dose bottle onto the operating table in a sterile field. Before opening the single-dose bottle verify the state of fluidity of the glue and its transparency. Open the single dose of Gluban Tiss® 2. Insert the transfer tip on the single dose, grabbing it near the neck to apply adequate pressure that allows the insertion of the tip. Gradually fill the cartridge by carefully pressing on the body of the single dose.

Also known as: Glubran Tiss

Glubran® Tiss

Comparator medical device PROCEDURE

Open the blister and pour the sterile single-dose bottle onto the operating table in a sterile field. Before opening the single-dose bottle verify the state of fluidity of the glue and its transparency. Open the single dose of Glubran® 2. Insert the transfer tip on the single dose, grabbing it near the neck to apply adequate pressure that allows the insertion of the tip. Gradually fill the cartridge by carefully pressing on the body of the single dose.

Also known as: Glubran 2

Glubran® 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No significant cardiopulmonary, hepatic, or renal impairment, and no contraindications for surgery;
• Clinical diagnosis of:
• bilateral inguinal hernia eligible for minimally invasive repair (TAPP-TEP VLS/ROB)
• recurrent monoliteral inguinal hernia (TAPP-TEP VLS/ROB)
• large inguinoscrotal hernias (TAPP-TEP ROB)
• primary ventral hernia with defects size ≤ 7cm (IPOM-TARUP-COSTA-THT-MILOS-eMILOS VLS/ROB)
• primary abdominal border hernia (idem VLS/ROB)
• post-incisional hernia with defect size ≤ 7cm (idem VLS)
• post-incisional hernia and complex abdomen (RIVES-RIVES+TAR ROB)
• swiss-cheese defects multiple small defects if treatable with only one mesh; if the total width of the defect is ≤ 5cm will be repaired by IPOM VLSM; if it is \> 5cm will be repaired by RIVES-RIVES+TAR ROB;
• Age \> 18 years, male and female;
• Obese patient (BMI\>35);
• Patients with ASA grade from I to III;
• Patients must sign and date the informed consent form prior to treatment.

You may not qualify if:

• Incarcerated hernia;
• Allergy to multiple classes of drugs, recent allergic disease, or use of drugs that are known harmful to vital organs during the 4 weeks before surgery;
• Patients with ASA IV or V;
• Participations in other clinical studies in the 3 months before surgery;
• Atopic allergy history;
• Mental illness history;
• Diseases that may significantly increase Intra-Abdominal Pressure (IAP) and cannot be effectively controlled such as severe ascites, severe asthma caused by bronchitis, pulmonary emphysema, or urine retention caused by significant Benign Prostatic Hyperplasia (BPH);
• Infection located at the surgical site or bacteraemia;
• Patients with collagenopathies;
• Relevant other concurrent diseases;
• Patient with neurological disorders and/or mood disorders;
• Hyperemotional patients;
• Pregnant women.

Sponsors & Collaborators

• GEM SRL: lead

Study Sites (1)

Ospedale Misericordia - U.O.C Chirurgia Generale e Mini-Invasiva.

Grosseto, 58100, Italy

Location

MeSH Terms

Interventions

glubran 2

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study plan will include a baseline visit (V1), in which eligible patients will be randomly assigned in one of the two groups: Group 1 will apply GLUTACK/Glubran® Tiss 2 whereas Group 2 GLUTACK-Glubran® 2. Application of surgical glue will be done by the surgeons, after a previous appropriate training, carried out by principal investigator (standardization application mode). Trial parameters will be recorded by a clinical evaluator at 24 hours (V2), 7 days (V3), 14 days (V4), 90 days (V5) and 180 days (V6). The last evaluation will be performed at V6, after 6 month.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: October 19, 2020
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

IT (1)