Hutchinson Santé Propose an Innovative Solution for Surgeons Which Deals With the Risk of Infection From Glove Breaches

PARIS, November 14, 2011 /PRNewswire/ --

After being the first to offer antiviral technology to protect healthcare professionals from contamination risks, Hutchinson Santé announces the launch of G-Bact^[TM] in Europe. This innovative solution will increase patient safety against nosocomial infections. The G-Bact^[TM] surgical glove contains an exclusive antimicrobial layer that kills more than 99% of bacteria* should there be a micro-breach in the glove.

Surgical site infections (SSI) are the number one cause of mortality during surgery^[1]. "In most cases, the germs come from the patient," declared Dr Jean Carlet, former chairman of CTIN (French National Technical Commission against Nosocomial Infections), and WHO consultant. "Other risk factors however can be attributed to the operating theatre environment: air quality, the use of insufficiently sterile equipment, perforated surgical gloves… On average, 18 % of surgical gloves become micro-perforated while being used.  80% of these glove breaches are not detected by the surgical staff^[2]. These breaches may enable bacteria from the surgeon's hand to be passed on to the patient. A recent clinical study showed that perforated gloves doubled the risk of SSI,"^[3] he continued. Double-gloving provides extra protection by limiting the perforation rate of the inner glove, but in 18 to 48% of cases, both layers are perforated in the same place^[2].  Moreover some surgeons are uncomfortable with the loss of dexterity caused by the thickness of the double-gloving, and by the layers slipping against each other.

G Bact^[TM] has been developed with the aim of providing an effective solution, which is comfortable and safe, to glove breaches issue and patient safety.

The G Bact^[TM] is made from a multi-layer synthetic film that is exceptionally resistant, watertight and reliable. The surgeon's touch sensitivity is not impaired. The glove has the thickness of a single-layered glove. If the glove is damaged during use, the physical failure is instantly compensated by the antimicrobial activity of the central layer that contains many reservoirs of a powerful antibacterial liquid. The "hand juice" passing through the glove comes into direct contact with the antibacterial agent and the bacteria are neutralised upon contact.

Specific in-vitro tests were developed to assess the efficacy of G-Bact^[TM] on common bacteria known to infect wounds*: Staphylococcus aureus, coagulase-negative Staphylococcus, Escherichia Coli and Candida Albicans. The results showed that the antibacterial glove G-Bact^[TM] reduces the number of bacteria passing through a glove breach by over 99% compared with a traditional surgical glove.

"The clinical evidence between perforated surgical gloves and the rate of surgical site infections was established recently^[3]. This study was what prompted the creation of G-Bact^[TM]," declared Pierre Hoerner, Director of Hutchinson Santé. "G-Bact^[TM] stems from our strategic desire to offer innovative solutions that combine safety and performance in the field of infection prevention in hospitals." : Safety, because the antibacterial layer is totally isolated between two watertight layers made of synthetic elastomer, which prevents prolonged contact with the antibacterial agent, both for the medical staff and the patient. The antibacterial liquid is only released if the glove becomes perforated, and only at the place of the perforation. This technology prevents prolonged occlusive contact between the hand and the antimicrobial agent, which could cause antibacterial resistance, as well as skin irritations and sensitization. Performance, because a sufficient amount of antibacterial agent is released in case of glove rupture to ensure quick effectiveness, even if a large quantity of germs pass through the glove, as it may happen when the skin is damaged at the same time as the glove.

G-Bact^[TM] represents a significant progress in terms of patient safety, in particular:

• for surgery involving the insertion of immunogenic material (prostheses, implants, transplants…); if a foreign body is present, a very low number of bacteria can trigger an infection^[4];
• during cardiac surgery;
• for patients with a depressed immune system.

The antibacterial surgical glove G-Bact^[TM] has been certified as a class IIa Medical Device in Europe since September 2011. The pre-announcement of the product launch was made at the International Conference on Prevention & Infection Control (ICPIC), which was held in Geneva. The official launch recently took place at the National Conference of Orthopaedic Surgeons organised by SOFCOT, which was held between 7 and 11 November 2011 in Paris. G-Bact^[TM] is now available in European countries.

History of Hutchinson Santé:

Hutchinson Santé was set up in 2004 to design and offer innovation solutions in the field of medical protection and the prevention of infections. Its first product was already a revolution: G-VIR^® is the first surgical glove in the world designed to protect the medical staff from the risk of viral contamination (AIDS, hepatitis C) in the event of blood exposure accidents (needlestick, cut with a sharp tool, contact with broken skin). In-vitro tests show that G-VIR^® reduces by 81% on average the number of viruses transferred in case of an accident with a hollow bore needle, compared with a double-layered glove^[5]. G-VIR^® therefore offers an exceptional and unrivalled level of protection for medical professional should they get injured! It is currently used in over 200 public health establishments in France, and is used in over 30 countries.

Bibliography

[1] http://www.u44.fr/nos/INFECT.pdf

[2] Widmer et al, Paper presented at 34 Interscience Conference on Antimicrobial Agents and Chemotherapy, Orlando, FL, 1994

[3] H. Misteli and Al, Arch Surg, 2009; 144 (6): 553-558

[4] Elek and al. British Journal of Experimental Pathology, 1957, 38:573-586

[5] R. Krikorian and al., J. Hosp Inf, 2007; Vol 3, N°5, 311-315

For more information, contact:
Mrs Christelle CHEROT
Product Manager - Hutchinson Santé
Tel.: +33-3-44-73-87-13
christelle.cherot@hutchinson.fr