First clinical study of a new virus-inhibiting surgical glove.

Question Under Study: Prospective clinical study to evaluate the tolerance, ergonomics and glove barrier value (mechanical resistance to breach) of a new surgical glove sandwiching droplets of a disinfecting agent between two layers of a synthetic elastomer (G-VIR) able to inactivate viruses when breached.
Methods: 100 surgical procedures were performed by six surgeons wearing G-VIR on 100 patients included after informed consent. Procedures were classified into laparoscopic (n = 28) or open surgery (n = 72); open surgery being subdivided either into superficial (n = 33) and deep (n = 39) or into hernia (n = 32) and non hernia (n = 40). The ergonomics and tolerance of the glove were evaluated by the surgeons using a questionnaire. Patients were clinically evaluated daily during hospitalization and once between the 4th to 6th postoperative week. All used gloves underwent a water leak test to detect any breach.
Results: 834 G-VIR gloves were used, 456 by the first surgeon and 378 by the assistant surgeon, resulting in 195 exposures, lasting 288 operator-hours (OH). No adverse effect on patients and/or surgeons linked to G-VIR could be observed. Ergonomics of G-VIR has been evaluated as equivalent as standard double gloving, excepted for donning which was more difficult (P <0.05). The breach rate per glove (BRpG) amounted to 1.8%. According to breach rate per operator-hour (BRpOH), surgical procedures could be categorized in low (laparoscopy), middle (non hernia and hernia superficial) and high (hernia deep) risk procedures.
Conclusions: G-VIR gloving offers an excellent mechanical protection, is suitable for daily surgical practice and maybe recommended in high risk surgical procedures.