Esposito, Emanuela (2020) Cyanoacrylate based glue in reducing seroma after axillary surgery. Preliminary results of the glubreast trial. [Tesi di dottorato]

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Item Type: Tesi di dottorato
Resource language: English
Title: Cyanoacrylate based glue in reducing seroma after axillary surgery. Preliminary results of the glubreast trial
Creators:
CreatorsEmail
Esposito, EmanuelaUNSPECIFIED
Date: 7 March 2020
Number of Pages: 43
Institution: Università degli Studi di Napoli Federico II
Department: Medicina Clinica e Chirurgia
Dottorato: Terapie avanzate medico-chirurgiche
Ciclo di dottorato: 32
Coordinatore del Corso di dottorato:
nomeemail
Di Minno, GiovanniUNSPECIFIED
Tutor:
nomeemail
De Palma, Giovanni DomenicoUNSPECIFIED
Date: 7 March 2020
Number of Pages: 43
Keywords: Cyanoacrylate, Axillary surgery, Glubreast
Settori scientifico-disciplinari del MIUR: Area 06 - Scienze mediche > MED/18 - Chirurgia generale
Date Deposited: 24 Mar 2020 11:24
Last Modified: 10 Nov 2021 14:15
URI: http://www.fedoa.unina.it/id/eprint/13022

Collection description

Axillary lymph node dissection is characterized by the risk of complications that tend to occur in 15 - 81% of cases according to existing literature. Such complications include seroma, haematoma, paresthesia, lymphocele, lymphorrhea and lymphedema. The most frequently reported complication in the literature is seroma, as a result of the bloody tissue that activates fibrinolysis in serum and lymph with subsequent collection of exudate in the spaces left free by the surgery itself. Cyanoacrylate based glue has been sponsored and advertised as medical device able to reduce axillary seroma after breast surgery. To confirm this we set up a randomised controlled phase III trial, called GLUBREAST Trial aimed to verify the effectiveness and the safety of the aforementioned cyanoacrylate based surgical glue introduced by a nebulizer inside the axillary space after axillary clearance for breast cancer. The aim of this study is to verify the efficacy of nebulized cyanoacrylate based surgical glue, namely (N-Butyl-2-CyanoAcrylate + Metacryloxisulfolane [NBCA + MS]), in the reduction of seroma after breast conserving surgery or mastectomy and ipsilateral axillary dissection in patients with breast cancer. Regarding the primary endpoint, the total volume of serum drained in the Experimental Arm is higher than the Control Arm (951.15 ml ± 427.0 ml Standard Deviation vs 795.3 ml ± Standard Deviation 560.9 ml), p < 0.004. Interestingly among secondary outcomes we noticed that by stratifying patients according to BMI the production of fluid was directly proportional to BMI, whereas in the Experimental Arm, the more the BMI increased the more the fluid decreased. To date GLUBREAST Trial represents one of the few trials testing medical devices. This is the case of a study where secondary endpoint have overcome primary.In conclusion, after preliminary data analysis GLUBREAST Trial is not showing clinical benefit with the use of cyanoacrylate based surgical glue in reducing the risk of seroma formation in the setting of breast surgery after axillary dissection. Experimental Arm and Control Arm showed no statistical significant difference in the total volume of fluid collected during follow up, disappointing the primary endpoint by now.

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