Cs the tulane_study[1]
- 1. ClinicalSummary DoubleGloving The Tulane Study Objectives 1. To evaluate the ability of participants to locate pre-drilled laser holes in surgical gloves. 2. To compare single vs double gloving. 3. To compare the Biogel® IndicatorTM Glove System with single and double glove configurations. The Tulane Study. Florman S et al. Efficacy of Double Gloving with an Intrinsic Indicator System. Surgical Infections 2005; 6: 385-394 The increased exposure to blood that comes with invasive surgery means a high risk of bloodborne pathogen transmission between patients and surgical staff. Reliability and efficacy of surgical gloves are therefore critical since they are the most important protective barrier between surgical staff and patients. However, glove puncture rates are as high as 78% in some types of surgery and even laparoscopy is associated with a 20% perforation rate.1 Also, glove punctures often go undetected - up to 92% of perforations pass undetected by surgeons and nurses, thus increasing the risk of exposure to the surgical team of cross-infection.2 It is estimated that 1 in 1500 surgeons will be infected by HIV due to damaged gloves over their professional lifetime.3 Background In order to protect both surgical teams and patients, it is critical that the glove barrier remains intact throughout the procedure. Wearing two pairs of gloves has been shown to decrease the risk of glove puncture by almost ten times.4 However, many surgeons continue to use single gloves, as they believe double gloving may compromise dexterity. As well as being efficacious, surgical gloves must be comfortable, easy to don, and any glove puncture must be detected easily. REG177 CS_The Tulane Study.qxp 15/12/06 09:17 Page 1
- 2. ClinicalSummary The Tulane Study This was a double-blind randomized study to evaluate the ability of participants to identify laser-drilled holes (30-micron) and to evaluate the Biogel Indicator system. Twenty-five participants simulated surgery, using beef and simulated blood in order to reproduce deep wound surgery. Participants were volunteer staff surgeons at Tulane University, Department of Surgery. Twenty glove configurations were used (8 single gloves, 12 double gloves) with half of the gloves pre-compromised with laser created holes. Four configurations were indicator systems (two latex and two non-latex), and the other 16 were non-Indicator. The simulated surgery was stopped when a hole was identified or when two minutes had passed. After testing each configuration, perceptions of gloves were then reported by participants on a questionnaire. The study evaluated fit, comfort, sensitivity, surface grip, overall feel and ease of donning. With the Biogel Indicator system participants found 84% of holes in an average of 22 seconds. With Biogel® Skinsense® Underglove and Biogel® Skinsense® Polyisoprene participants found 56% of holes in an average of 42 seconds. In the worst performing non-latex configurations participants found 8% of holes in an average of 47 seconds. Results Methodology In the worst performing latex configurations participants found 12% of holes in an average of 67 seconds. Biogel Indicator gloves were highly rated for fit, comfort, sensitivity and ease of use. The Tulane study concludes that there is no acceptable explanation for not double gloving and for not doing so with an indication system. • The BiogelIndicator system provides the best protection and allows for rapid, dramatic and obvious identification of glove punctures. • Double gloving does not compromise comfort, sensitivity or ease of use. References 1. Florman S et al. Surgical Infections, 2005; 6: 385-394 2. Maffulli N et al. J Hand Surg. 1991; 1, 6A: 1034-7 3. Palmer J D and Rickett JWS. J Hosp Infect 1992; 22: 279-286 4. Gani JS et al. Aust NZ J Surg 1999; 3(60): 171-5 Key Points Summary For further information on any of the above, please contact your local dealer or Mölnlycke Health Care directly at the address below. This summary is provided as a courtesy by Mölnlycke Health Care. Mölnlycke Health Care has attempted to accurately summarise the significant issue discussed in the published study but makes no representation as to the accuracy or completeness of the summary. We refer the reader to the actual study for more information. Mölnlycke Health Care will provide reprints on request. Mölnlycke Health Care Ltd, Two Omega Drive, Irlam, Manchester, M44 5BJ, UK. T 0161 777 2600. F 0161 777 2601. E biogel@molnlycke.com www.molnlycke.com The Mölnlycke Health Care name and logo and Biogel® , IndicatorTM , Skinsense® and the hands device trademarks are registered globally to Mölnlycke Health Care. REG177-7-1106 SETTING THE STANDARD IN PROTECTION Biogel ® REG177 CS_The Tulane Study.qxp 15/12/06 09:17 Page 2