Today, sterile surgical gloves are used to provide two-way protection: to protect patients from infection during surgery and to provide protection of healthcare workers (HCW) from exposure to bloodborne pathogens. Historically, the use of latex gloves in the OR dates back to the nineteenth century when they were initially used to protect the hands of OR nurses and eventually used by surgeons as a protective hand barrier to protect the patient from microorganisms (Halstead, 1913). Today, there are a variety of surgical latex gloves available ranging from powder to powder free, thick versus thin, specialty versus general surgery, and textured versus smooth (Korniewicz & Kelly, 1995).1 With reports of an increased risk to latex allergy (Sussman, 1998),2 HCW have begun to use non-latex gloves as a substitute for natural rubber latex for surgical cases in patients who are allergic to latex and among HCW who have been diagnosed with a latex allergy. However, little is known about the use of non-latex gloves during surgery since they have not been routinely used.
Non-latex gloves are manufactured from man-made versus natural rubber compounds and are primarily composed of materials such as neoprene, nitrile, or polyurethane. To date, Rego and Roley (1999)3 reported that non-latex medical gloves such as nitrile were comparable to latex when used for basic patient care procedures, however, there are no studies that investigate the barrier quality of non-latex surgical gloves.
Purpose
The purpose of this study was to evaluate the number of glove leaks and patterns of use during routine surgical procedures of non-latex sterile surgical gloves and to evaluate self-reported HCW satisfaction. The overall clinical research questions included: 1) do non-latex surgical gloves offer the same barrier protection for surgeons and healthcare workers (HCW) as latex surgical gloves; 2) do non-latex surgical gloves provide more or less HCW protection against needle stick punctures or tears; and 3) do HCW find non-latex surgical gloves more acceptable for use when performing routine surgery?
Methods
In order to collect information about the use of non-latex surgical gloves, a federally funded research study4 was implemented in 23 operating room suites at a major university hospital. The surgical services complete over 10,000 major surgeries annually. All services (cardiac, orthopedic, neuro, general, OB-GYN, ENT, G.I., pediatric, etc) have been included in the l2-month data collection period. Data collection was started in June 1999 and completion of the data collection is projected to be August 2000.
Study design: The project was designed to test the qualities of non-latex surgical gloves after use.5 Every other month, a different non-latex glove brand was supplied for each of the surgical suites. This alternating block design was used to assure consistency, accuracy, and continuity of data collection methods. The circulating nurses assisted in the data collection by reminding surgical personnel to use the study glove as well as providing assistance during the overall data collection period. For our purposes, gloves were collected only from the OR staff who were directly involved in the surgery: attending surgeon, first assist, resident and scrub person. Several steps were implemented to include appropriate glove distribution, staff participation, glove collection, transportation, and laboratory glove testing (Table 1).
User satisfaction form: At the end of each month, all perioperative staff and physicians who used the study glove were asked to complete a "user satisfaction form." This form provided information about each participant's evaluation of the quality, safety, serviceability, standardization, perception of needle stick injury and durability of each study glove. Additional comments were routinely solicited about the use of the study glove from all participants.
Data analysis: The data set is large and includes the glove, laboratory, operating room, participant, demographic and user satisfaction data. For each glove tested there are over 600 possible data items to be considered and entered. Much of the glove data being collected is categorical, dichotomous data while the demographic and user satisfaction data will include rating scales. These data provide possibilities for comparisons of the characteristics of barrier effectiveness among the types of non-latex surgical gloves tested. Analyses exploring the relationships between glove integrity and surgical use, type of participant, participant demographic data and user satisfaction will be conducted.
Preliminary Results
To date, over 600 HCW (surgeon, resident, first assist, scrub personnel, Table 2) have participated in the study with data on over 12,703 gloves (latex 6336; non-latex 6337). All surgical services have participated in the study with the highest glove collection rates from orthopedic surgeons (14.1%, 1797/12703) to the least collected from thoracic surgeons (2.3%, 301/12703).
Summary
All data on this project should be collected by August, 2000 and conclusions reached by the end of the year. As soon as these conclusions are available they will be published in the AnsellCares Source to Surgery Newsletter.
REFERENCES
- Korniewicz D & Kelly K. (1995). Barrier protection and latex allergy. AORN 61:1037-1044
- Sussman G, Liss G, Deal K et al. (1998). Incidence of latex sensitization among latex glove users.
J Allergy Clin Immunol 101: 171-178.
- Rego A & Roley L (1999). In-use barrier integrity of gloves: latex and nitrile superior to vinyl. AJIC October: 405-410.
- National Institute for Occupational Safety and Health, Department of Health and Human Services:
Alert: Prevention Allergic Reactions to Natural Rubber Latex in the Workplace (1997). 97:135.
- U.S. Food & Drug Administration: Medica devices: Current good manufacturing practice (CGMP) final rule: Quality system regulation. Federal Register 61:52601-52662. (1996).
