Self protection in surgery: the use of double gloves

This study assesses the perforation rate of single and double gloves and thus the extent to which double gloving protects the surgeon from diseases transmissible from the patient. We have also investigated whether double gloving offers the patient extra protection by reducing wound sepsis. Two hundred adult hernia repairs were performed, the first 100 single gloved and the second 100 double gloved. Glove perforation rates were not significantly different between single gloves and the outer of the double gloves. Although 46 of 400 outer gloves were perforated there were only 15 inner glove perforations and only eight of these matched the outer perforations. The percentage of operations in which the latex protective barrier was breached was reduced from 31 per cent when the surgeon wore single gloves to 8 per cent with double gloves. Wound sepsis was not increased by glove perforation nor reduced by double gloving. While careful technique remains mandatory we conclude that double gloving offers increased protection to the surgeon operating on high risk infectious cases.     

Ease of donning of new powder-free non-latex and latex double-glove hole puncture indication systems

Cornstarch on surgical gloves is often used as a detackifying agent and a lubricant to facilitate glove donning. During the last century, scientific studies have demonstrated that cornstarch produces tissue injury in literally every part of the body. Because this glove lubricant cannot be removed from the glove, Dr. David Podell, an ophthalmologic surgeon, and his cousin, Howard Podell, a chemical engineer, devised the first powder-free surgical glove that could be donned easily. They coated the inner surface of the surgical glove with a methacrylate polymer lining that was bonded to the natural rubber latex. This special coating acts as a lubricant to facilitate donning with damp, wet, or dry hands. In our earlier experimental studies, we confirmed that these polymer-lined latex gloves could be donned with either wet or dry hands. More recently, the polymer-coated latex gloves were incorporated into a double-glove hole puncture indication system that accurately detected glove holes in the presence of fluid. Because this discovery has been expanded into the development of a non-latex double-glove hole puncture indication system, we have expanded our biomechanical performance studies to examine the glove donning forces of the latex and non-latex glove hole puncture indication systems. The maximum donning forces recorded for the non-latex undergloves were significantly lower than those encountered by the same respective sizes of the latex underglove. The donning forces of the thin Biogel Super-Sensitive outer gloves were remarkably similar to the donning forces of the Biogel Indicator undergloves. The thicker Biogel outer gloves encountered greater donning forces than that noted for the Biogel Super-Sensitive outer gloves. The donning forces recorded for the non-latex outer gloves were remarkably similar to those noted for the latex Biogel outer gloves. Because the results of this biomechanical performance study demonstrated that the latex and non-latex double-glove hole puncture indication systems can be easily donned by surgeons using relatively low donning forces, this study provides convincing evidence that these double-glove hole puncture indication systems can be used in all surgical procedures.     

Reliability and performance of innovative surgical double-glove hole puncture indication systems

During operative procedures, operating room personnel wear sterile surgical gloves designed to protect them and their patients against transmissible infections. The Food and Drug Administration (FDA) has set compliance policy guides for manufacturers of gloves. The FDA allows surgeons' gloves whose leakage defect rates do not exceed 1.5 acceptable quality level (AQL) to be used in operating rooms. The implications of this policy are potentially enormous to operating room personnel and patients. This unacceptable risk to the personnel and patient could be significantly reduced by the use of sterile double surgical gloves. Because double-gloves are also susceptible to needle puncture, a double-glove hole indication system is urgently needed to immediately detect surgical needle glove punctures. This warning would allow surgeons to remove the double-gloves, wash their hands, and then don a sterile set of double-gloves with an indication system. During the last decade, Regent Medical has devised non-latex and latex double-glove hole puncture indication systems. The purpose of this comprehensive study is to detect the accuracy of the non-latex and latex double-glove hole puncture indication systems using five commonly used sterile surgical needles: the taper point surgical needle, tapercut surgical needle, reverse cutting edge surgical needle, taper cardiopoint surgical needle, and spatula surgical needle. After subjecting both the non-latex and latex double-glove hole puncture indication systems to surgical needle puncture in each glove fingertip, these double-glove systems were immersed in a sterile basin of saline, after which the double-gloved hands manipulated surgical instruments. Within two minutes, both the non-latex and latex hole puncture indication systems accurately detected needle punctures in all of the surgical gloves, regardless of the dimensions of the surgical needles. In addition, the size of the color change visualized through the translucent outer glove did not correlate with needle diameter. On the basis of this extensive experimental evaluation, both the non-latex and latex double-glove hole puncture indication systems should be used in all operative procedures by all operating room personnel.     

Can double gloves improve surgeon-patient barrier efficiency?

The aim of this study was to compare double gloves (DGs) with single gloves (SGs) during orthopedic and trauma surgery in prevention of blood contact between patients and surgeons. DGs and SGs were collected after orthopedic operations, tested for size, site, and number of perforations. Medical records were reviewed for age, sex, type of operation, duration, and postoperative wound infection. Data were compared using t-test with level of statistical significance at P < 0.05. Five hundred seven operations yielded 1204 DGs and 830 pairs SGs. In DGs, perforations were detected in 220 outer glove and 39 inner glove (10.7%). In SGs, 226 perforations were detected (13.3%). The incidence of perforations in inner gloves of the double indicator glove was 1.6% (P < 0.001). During surgery, perforations were recognized in DGs in 67% compared with 12% in SGs (P < 0.005). This study confirms that DGs form an efficient barrier between patients and surgeons.     

How often does glove perforation occur in surgery? Comparison between single gloves and a double-gloving system

BACKGROUND: In surgery, intact gloves protect the surgeon from bloodborne pathogens and the surgical wound from microorganisms on the skin of the surgeon. However, glove perforation is very common, and puncture rates as high as 61% are published in the literature. One objective of this study was to compare puncture rates between a unique double-gloving puncture indication system and single-use gloves, and another was to determine the extent to which glove perforations remain undetected during surgery. METHODS: The study material comprised all gloves used in surgical operations at our hospital for a period of 2 months. The analysis was made by the glove type in a prospective and randomized manner. Gloves were tested immediately after the surgical procedure using the approved standardized water-leak method for 2 minutes to detect any holes. The gloves used in this study were either a double-gloving puncture indication system or the standard glove used at our hospital. RESULTS: In 885 operations altogether, 2,462 gloves were tested; 1,020 single gloves, 1,148 double-glove systems, and 294 combination gloves were studied. The overall perforation rate was 192 out of 2,462 gloves (7.80%), and 162 out of 885 operations (18.3%). The detection of perforation during surgery was 28 out of 76 (36.84%) with single gloves, 77 out of 89 with the double-gloving system (86.52%), and 9 out of 27 with combination gloves (33.33%; P <0.001). The inner glove of the double-gloving system was punctured in 6 out of 88 outer glove perforations (6.82%). CONCLUSIONS: In view of the critical importance of safety at work by having a sterile barrier between surgeon and patient, it is very important to use a double-gloving puncture indication system, at least in operations where there is a high risk of glove perforation.     

Reducing accidental injuries during surgery

Extensive clinical investigations have demonstrated that double-gloves and blunt-tipped surgical needles dramatically reduced the risk of accidental injuries during surgery. During the last decade, double-glove hole puncture indication systems have been developed that reduce the clinical risk of accidental needlestick injuries as well as detect the presence of glove hole puncture in the presence of fluids. When the outer glove is punctured, the colored underglove becomes apparent through the translucent outer glove, necessitating glove removal, hand washing, and donning of another double-glove hole puncture Indicator system. This article presents the first biomechanical performance study that documents the puncture resistance of blunt surgical needles in latex and nonlatex single gloves and double-glove hole puncture indication systems. The technique for measuring glove puncture resistance simulates the standard test for material resistance to puncture outlined by the American Society for Testing and Materials. The maximum puncture resistance force was measured by the compression load cell and recorded in grams with a strip chart recorder. Ten puncture resistance measurements for the taper point needle, blunt taper point needle, and blunt needle were taken from five samples of the Biogel Indicator underglove, Biogel Super-Sensitive glove, Biogel glove, Biogel Skinsense N Universal underglove, and Biogel Skinsense Polyisoprene glove; and the Biogel, Biogel Super-Sensitive, and Biogel Skinsense Polyisoprene double-glove hole puncture indication systems. The magnitude of puncture resistance forces recorded was influenced by several factors: glove material, number of glove layers, and type of surgical needle. For each type of curved surgical needle,the resistance to needle penetration by the nonlatex gloves was significantly greater than those encountered by the latex glove materials. The resistance to needle puncture of all three double-glove systems was significantly greater than that of either the nonlatex or latex underglove or outer glove. The taper point needle encountered the lowest puncture resistance forces in the five single gloves and the three double-glove systems. Blunting the sharp end of the taper point needle markedly increased its resistance to glove puncture in the five single gloves and five double-glove systems. The blunt-point surgical needle elicited the greatest needle penetration force in all of the single and double-glove systems.     

Incidence of glove perforations in gastrointestinal surgery and the protective effect of double gloves: a prospective, randomised controlled study.

OBJECTIVE: To investigate the incidence of glove perforations during various types of gastrointestinal surgery, to record the incidence of blood contamination of the hands, and to evaluate the protective effect of double gloving. DESIGN: Randomised prospective trial. SETTING: University hospital, Denmark. MATERIAL: 566 pairs of gloves tested on surgeons, assistants, and scrub nurses. INTERVENTIONS: The participants were allocated to wear either single gloves or Indicator double gloves. MAIN OUTCOME MEASURES: The number of glove perforations and the incidence of blood contamination of the hands. RESULTS: The perforation rate in single gloves was 53/306 (17%), and that of both outer and inner Indicator gloves at corresponding sites was 6/260 (2%) (p < 0.0001). Double gloving reduced the rate of blood contamination of the hands among surgeons from 15/115 (13%) to 2/98 (2%) (p < 0.005). CONCLUSION: The use of Indicator double gloves is recommended in gastrointestinal surgery because of the appreciable protection against blood contamination that they offer.     

Glove Perforation in Outpatient Dermatologic Surgery

BACKGROUND: Intact surgical gloves ensure protection of health-care employees and health-care recipients. Nevertheless, glove perforation is very common and puncture rates above 50% have been published in the literature. OBJECTIVE: It was our aim to evaluate the perforation rate of surgical gloves in outpatient dermatologic surgery. METHODS: Six-hundred and sixty latex surgical gloves used in outpatient dermatologic surgery were evaluated for perforations using the approved water-leak method. Perforations were analyzed microscopically. RESULTS: Twenty of the 660 gloves were found to have perforations, which corresponds to a perforation rate of 3.0%. Only 5 of these perforations (25%) were noticed by the wearer. Perforations were more numerous in nondominant-handed gloves. Microscopically, all perforations could be identified as needle stick injuries. CONCLUSION: The risk of glove perforation in outpatient dermatologic surgery is lower than in many other medical specialties. The relatively high number of surgical procedures performed successively in outpatient dermatologic surgery, however, emphasizes the decisive relevance of an intact barrier between surgeon and patient. In view of the major fact that most perforations go unnoticed by the wearer, dermatologic surgeons must balance the improved safety of double gloving with costs and the loss of sensitivity and dexterity.     

Efficacy of double versus single gloving in protecting the operating team

Double-glove perforation rates and perforation rates in standard single-gloved operating teams were compared, in order to determine whether double gloving provides additional protection for the operating team. Patients were randomized to undergo surgery with a double-gloved or single-gloved operating team. All gloves worn during the operation were tested for perforations by water-filling and individual digital distension; 115 single-gloved operations and 103 double-gloved operations were performed. There were 841 individual operating team members 'at risk'. In the single-glove group, 20.8% of individuals had perforations, but only 2.5% had perforations in both inner and outer gloves (dual perforation) in the double-glove group (P less than 0.0001). The surgeon was most at risk of glove perforation (34.7% of cases in the single-glove group, 3.8% dual perforation in the double-glove group). Longer operations were associated with increased risk of glove perforation. Double-gloving significantly reduces the risk of skin contamination by blood and body fluids and is recommended for all high risk cases.     

Double or single gloves: which is safer in pediatric orthopedic surgery

BACKGROUND AND AIM: Surgical gloves should form an efficient barrier between surgeons and patients to prevent cross infection. Single gloves (SGs) have long been reported unsafe, and usage of double gloves (DGs) is still not universal. No study has reported the usage of DGs in pediatric orthopedic operations. The aim of this study was to assess the efficacy of DGs versus SGs in prevention of body fluid contact between patients and surgeons during pediatric orthopedic surgery. METHODOLOGY: After 150 pediatric orthopedic operations, DGs and SGs were collected and tested for perforations. Gloves were tested for size, site, and number of perforations among principal surgeons, assistant surgeons, and scrub nurses. Gloves were not changed during long surgical procedures and were changed only if perforations were identified and recorded. The DGs used were Maxitex Duplex, powder-free indicator gloves and the SGs were of Gammex-Ansell. One hundred unused gloves of each group were tested as controls. Medical records of the patients were reviewed for age, sex, type of operation, duration of operation, and any postoperative wound infection. The data were entered in database and analyzed using SPSS package. The data were compared between double and SGs using t test with a level of statistical significance at P less than 0.05. RESULTS: Five hundred twenty-six DGs and 316 SGs were tested. Forty-three perforations were detected in DGs (8.1%). Outer gloves were breached in 7.8% and inner in 0.3% as compared with SGs in which 28 (8.7%) were perforated. In DGs, 4% had multiple perforations compared with 11.9% in SGs. There was a statistical significance (P<0.001) when the perforations of inner gloves were compared with the SGs. None of the inner perforations were recognized during surgery, but the outer gloves of the DGs were recognized in 71% as compared with 9% in SGs (P<0.001). The majority of perforations were seen in the nondominant hand in surgeons and assistants hands, whereas scrub nurses had 85% of perforations in the dominant hand. The index finger was the site of perforations in DGs (53.4%; SGs, 43%). The inner gloves were breached only when the outer glove was found to be perforated. The duration of surgery had a direct impact on the number of perforations. There were no perforations in DGs in less than 60 minutes as compared with 3 (10.7%) in SGs. Between 60 and 120 minutes, the perforations in the DGs were 11, and in SGs, 21. During the study period, 4 patients had surgical site infection. Three were superficial and one deep-seated infection. In 3 patients with infection, the gloves were found to be perforated, and 1 patient with infection had no perforations in the gloves. CONCLUSION: Our study confirms that DGs are safer than SGs during pediatric orthopedic operations. In the event of nonavailability of DGs, SGs should be changed on an hourly basis during long procedures. Lastly, there exists a relationship between surgical site infection and glove perforations.     

A randomised trial of the durability of non-allergenic latex-free surgical gloves versus latex gloves.

A prospective randomised trial was performed to compare the robustness of a new non-latex surgical glove with a standard latex glove when worn by four general surgeons in a district general hospital. Gloves were retrieved after surgery and examined using the European Standard Test for punctures. The overall puncture rate was 10.1%, and there was no significant difference in the rates between the two types of glove, although punctures in the non-latex glove tended to be larger and more readily noted by the wearer. The increase in latex allergy among health care staff dictates the need for gloves made from other materials, which may also be useful for operations on latex-allergic patients.     

Resistance of double-glove hole puncture indication systems to surgical needle puncture

Double-gloving has been shown to reduce conclusively the risk of operating room personnel's exposure to blood. Limiting risk of exposure to blood by double-gloving provides protection against the transmission of bloodborne diseases. Realizing the importance of double-gloving, a double-glove hole puncture indication system exists that accurately detects the presence of glove hole puncture in the presence of fluid. Once a glove puncture is recognized by this double-glove hole puncture indication system, it provides a warning to the surgeon to remove the punctured gloves, wash hands, and don a new, sterile double-glove hole puncture indication system. While accurately identifying the presence of glove hole puncture in the presence of fluid, this double-glove hole puncture indication system also has resistance to needle puncture superior to that of single gloves. It is the purpose of this study to document the resistance to needle puncture of latex and non-latex double-glove hole puncture indication systems using a reproducible experimental model. The resistance to needle puncture of the double-glove systems was significantly greater than that of the undergloves or outer gloves alone. The resistance to glove puncture of the non-latex and latex single and double-glove systems was significantly greater than those encountered by the latex single and double-glove systems, respectively. On the basis of their accuracy in detecting glove hole puncture, combined with their demonstrated superior resistance to surgical needle puncture as compared to single gloves, these latex and non-latex double-glove hole puncture indication systems are recommended for all surgical procedures.     

Glove perforation during plastic surgery

Intraoperative perforation of surgical gloves is common. Nine hundred and forty surgical gloves were tested after 100 consecutive plastic surgical operations, each involving a surgeon, a variable number of assistants and a scrub nurse. In the first 52 operations, single gloves were used and 21.5% of the staff were found to have a perforated glove. In the second 48 operations, double gloves were used by all members of the surgical team and the number with perforations (of both inner and outer gloves) was reduced to 9%. Most perforations occurred on the dorsum of the hand and fingers and on the thumb tip, especially in the non-dominant hand. The risk of acquiring AIDS due to glove perforation is low but the consequences of such an event could be lethal.     

Glove perforation rate in open lung surgery.

OBJECTIVE: In open lung surgery the surgical access is encircled by the ribs, which should result in a high glove perforation rate compared with other surgical specialities. METHODS: Prospectively the surgeon, first and second assistant and the scrub nurse wore double standard latex gloves during 100 thoracotomies. Parameters recorded were: procedure performed, number of perforations, localization of perforation, the seniority of the surgeon, manoeuvre performed at the moment of perforation, immediate cause of perforation, operation time, performance of rib resection during thoracotomy and time of occurrence of the first three perforations. RESULTS: One thousand, six hundred and seventy-three gloves (902 outer, 771 inner) were tested. In 78 operations perforations occurred. There were 150 outer glove perforations (8.9%, 0-8, mean 1.23), 19 inner glove perforations (1.13%, 0-2, mean 0.19). Cutaneous blood exposure was prevented in 78% of all operations and in 87% of all perforations. The perforation rate for the surgeon, the scrub nurse, the first and the second assistant were 61.2, 40.4, 9.7 and 3.1% of all operations, respectively. Rib resection and a duration of more than 2 h resulted in a significant rise of glove perforation rate (P<0.05). The personal experience of the surgeon and the type of operation did not correlate with glove perforation. The immediate cause leading to perforation was named in only 17 cases (13.7%) and comprised contact with bone (seven), a needle stitch (seven) and a production flaw (three). Leaks were localized mostly on the first finger (18%),second finger, (39%) palm and dorsum of the hand (16%). The average occurrence of all first perforations was 38.7 min (range 3-190) after the beginning of surgery, the second after 63.2 min (range 10-195). Fifty-four first perforations (50.5%) were found during the first 30 min of the operation. CONCLUSIONS: The reported perforation rate of 78% lies in the highest range of reported perforation rates in different surgical specialities. Double gloving effectively prevented cutaneous blood exposure and thus should become a routine for the thoracic surgeon to prevent transmission of infectious diseases from the patient to the surgeon.     

Glove punctures in an orthopaedic trauma unit

A series of 421 operations in an orthopaedic trauma unit have been studied for glove punctures; 37.5 per cent of operations had a puncture demonstrated in the surgeon's gloves. The procedures at a high risk of glove punctures were hip operations (57 per cent) and internal fixation (54 per cent). The use of double gloving reduced the contamination of the surgeon's hand in these operation groups to 17 per cent (P less than 0.05). The potential risk of the surgeon being infected by his patients has become increasingly important with the increase in the number of people infected with HIV. The trauma surgeon is at a high risk due to frequent spillage of body fluids in trauma and the difficulty in identifying patients who may be at risk. Reducing the risk to the surgeon is difficult but awareness of the areas of potential contamination such as glove puncture may help.     

Anticipated Detection of Imminent Surgeon–Patient Barrier Breaches. A Prospective Randomized Controlled Trial Using an Indicator Underglove System

The double gloving indicator underglove system (IUS) is based on a colored detection of the outer glove perforation. Our objective was to determine the IUS efficiency to detect outer glove perforations and to reduce the risks of blood and body fluids exposure, warning the surgeon before the breach of the surgeon–patient barrier (SPB). A series of 100 visceral surgical procedures were randomly assigned to either double (IUS) or single gloving. The noticed glove perforations (using the water test method) and the IUS efficiency were analyzed in 99 procedures. In 49 single-gloving procedures, 19 perforations were noticed: one was immediately perceived (perceived accidental exposure, PAE); 3 were discovered as the gloves were being removed, and 15 were undetected before the water test (unperceived prolonged contact, UPC). In 50 double-gloving procedures (IUS), 16 perforations were noticed, all of them involving only the outer glove: the IUS allowed immediate detection of 3 perforations without any blood exposure; 13 other perforations went undetected but without any UPC. In conjunction with the protective quality of double gloving, the IUS allows detection of significant breaches of the outer glove before the breach of the SPB.     

Surgical glove failure rate

Surgical gloves were collected after day-time operations for a 4-week period. Glove punctures were located by inflating each glove with compressed air and immersing the inflated glove in water. During the period of the study 681 surgical operations were performed. A total of 3790 gloves was collected, 334 gloves (8.8%) had perforations at the end of the surgical procedure. Defects occurred in one or more gloves in 32.0% of all operations.     

Control of contamination of the operative team in total joint arthroplasty.

Reports of percutaneous transmission of blood-borne disease emphasize the need for control of intraoperative contamination. In a randomized prospective study, surgeons and surgical assistants involved in total hip and total knee arthroplasty adopted the following protocol: total body exhaust with hood, aspirator, knee-length impermeable gowns, foot covers, including knee-high covers and waterproof covers, and one of three combinations of gloving protocols: latex/latex changed hourly, latex/cloth, or latex/cloth/latex. All inner gloves were tested by a leak test. All needles and sharp instruments were passed on trays, and all contaminations and perforations were recorded. Each surgeon and assistant was inspected twice for contamination. There were no needle sticks, and only one of 267 personnel had head, neck, body, leg, or foot contamination. Perforation rates of inner gloves were 9.2% for latex/latex, 7.9% for latex/cloth, and 4.3% for latex/cloth/latex.     

Surgical glove use in France

Since the end of the 19th century, surgeons have used gloves to prevent infectious complications to the patient. The AIDS epidemic of the 1980's sparked the use of universal precautions to protect the surgeon from infection and vice-versa. The interface between surgeon and patient is in effect a two-way street. Surgical techniques must be modified and barrier protection optimized to minimize these risks. A single layer glove is a fragile barrier to blood exposure; unrecognized glove perforations may lead to unrecognized and prolonged exposure. Double gloving, though far from being a widespread practice in France, seems to be the best protection from pathogen exposure. Glove powder and latex allergies have their own inherent risks to both surgeon and patient in the form of latex allergies and adhesive peritonitis. New institutional protocols will be necesssary in order to make powder-free non-latex gloves available to French surgeons.     

Needlestick injuries at operations for trauma. Are surgical gloves an effective barrier?

Surgeons are at risk from both hepatitis B and human immunodeficiency viruses. While vaccines have been developed against the former, barrier methods remain the mainstay of protection. Puncture wounds of the hand are a potential source of contamination; the protection afforded by surgical gloves has been investigated. Gloves from 280 orthopaedic operations for trauma were tested for perforations; one or more was found after 30% of the operations in gloves worn by the surgeon or scrub nurse. About 60% of the perforations were noticed at the time of penetration and most affected the dominant thumb and index finger. Puncture was more common during operations lasting more than one hour. The incidence of perforation was 19% for the outer of double gloves, 14% for a single glove and 6% for the inner of double gloves. These results indicate that surgical gloves function poorly as a protective barrier, especially in difficult, lengthy, fracture surgery. The practice of double-gloving confers increased but not absolute protection.