SCIENTIFIC ARTICLE
Incidence of Glove Perforation During Hand Surgical Procedures Kevin F. Lutsky, MD,* Christopher Jones, MD,* Jack Abboudi, MD,* William Kirkpatrick, MD,* Fred Liss, MD,* Charles Leinberry, MD,* Asif Ilyas, MD,* Dennis Martin, MS,* Pedro K. Beredjiklian, MD*
Purpose To determine the rate of glove perforation during hand surgery. Methods We prospectively examined the rate of glove perforations among 10 fellowshiptrained hand surgeons at our institution during a 6 week period. Gloves were tested for perforation using a water-fill technique at the conclusion of each surgical procedure. Surgeons recorded the presence of any glove perforations. Results Eleven perforations were identified in 10 gloves among 600 surgical procedures during the study period. The perforation rate per case was 1.5% (95% confidence interval, 0.78% to 2.8%). Forty percent of perforations (n ¼ 4) occurred during fracture surgery. Other holes occurred during isolated carpal tunnel release (n ¼ 3) or combined carpal tunnel and trigger finger release (n ¼ 3). The perforation was noticed intraoperatively in only 2 gloves. The difference in perforation rate between single- and double-gloved procedures was not significant. There were no perforations in the inner glove of surgeons who double gloved. A total of 73% of holes (8 of 11) occurred on surgeons’ index finger; 75% of these were on the dominant hand. The dominant thumb, non-dominant ring and nondominant little fingers each had a single perforation. Conclusions The rate of glove perforation during hand surgery is low. Holes can occur even during soft tissue procedures of short duration. The dominant index finger appears to be at greatest risk for perforation. When they do occur, most often holes are not noticed by the operating surgeon. The baseline glove perforation rate is unknown. Clinical relevance A high level of vigilance is required to maintain sterile technique. (J Hand Surg Am. 2017;-(-):1.e1-e5. Copyright Ó 2017 by the American Society for Surgery of the Hand. All rights reserved.) Key words Glove perforation.
T
to the late 19th century. Caroline Hampton, the scrub nurse in the operating room of William Stewart Halsted, developed contact dermatitis in her hands from phenol and mercuric chloride, commonly HE USE OF SURGICAL GLOVES DATES
From *Hand and Upper Extremity Surgery, The Rothman Institute, 925 Chestnut Street, Philadelphia, PA. Received for publication December 22, 2016; accepted in revised form June 28, 2017. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article.
used as surgical disinfectants. To address the problem, Dr. Halsted, chief of surgery at Johns Hopkins Hospital, commissioned the Goodyear Rubber Company to create thin rubber gloves to protect his nurse. The use of surgical gloves became commonplace among Corresponding author: Kevin F. Lutsky, MD, Hand and Upper Extremity Surgery, The Rothman Institute, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107; e-mail: Kevin. [email protected]. 0363-5023/17/---0001$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2017.06.103
Ó 2017 ASSH
r
Published by Elsevier, Inc. All rights reserved.
r
1.e1
1.e2
GLOVE PERFORATION
other nurses, and eventually surgeons adopted the practice. Joseph Bloodgood, one of Dr. Halsted’s protégés, reported a near 100% drop in infection rate in over 450 hernia surgeries with the use of gloves in 1899. In light of this success, Dr. Halsted and many of his contemporaries adopted the routine use of gloves during surgical procedures.1 For the hands of the surgeon, the surgical glove provides a barrier to isolate the skin surface of the surgical team from the patient. Glove perforation results in a break in this barrier, which can potentially result in wound contamination and expose the surgeon and patient to pathogens. In 1991, Maffulli et al2 examined the rate of latex glove perforation in hand surgical cases and found a rate of 19%. Most of these perforations were not detected by the operating surgeon during the procedure. This rate of glove perforation seems high, given that our anecdotal experience suggested that glove perforations are rare during hand surgery. However, based on the experience of Maffulli et al and others,3 holes may occur much more frequently than we are aware, and even close intraoperative inspection of a potentially compromised glove may be inadequate to detect a perforation. Surgical practice has changed considerably since the report of Maffulli et al2 nearly 25 years ago. Procedures such as volar plating of distal radius fractures have become far more common4 whereas implants have become more refined with features including smooth, tapered edges and precontours5 that may be less likely to cause perforations. Many surgeons have adopted wide-awake local anesthesia with no tourniquet, which can result in a bloodier surgical field.6 Many surgical procedures such as carpal tunnel release (CTR) and cubital tunnel release are being performed through more minimally invasive and/or endoscopic approaches, and glove manufacturing techniques and quality control measures have been modified over the past quarter century.7 Therefore, the purpose of our study was to evaluate the rate of surgical glove perforation during common hand surgical procedures. We hypothesized that these changes would result overall in a lower rate of glove perforation than previously reported.
believed that excluding trauma patients would eliminate some degree of variability, because these surgeries are often performed at off hours, with an unfamiliar team, and in an uncontrolled setting. During this time, surgeons recorded the presence of any glove perforations noted during the surgical procedure. If a perforation was noticed during the procedure, the location (side, digit, and outer/inner glove) was recorded. If no perforation was noted during the procedure, the surgeon tested each of the outer and inner gloves for perforations at the conclusion of surgery. The method used to detect holes was a water-fill technique identical to that used by Maffulli et al2 and described by McCue et al,8 which is validated for determining holes equivalent to the size of a 26gauge needle and larger. Each glove was overfilled with water and then squeezed, both at the base of the glove to pressurize the palm and along each digit. A perforation was noted as a stream of water. For surgeons who used double gloves, the same analysis was performed for both the inner and outer gloves. The gloves of surgical assistants were not tested. Surgeons also recorded the following variables: type of procedure, type of anesthesia, surgical or tourniquet time, glove type, and use of single or double gloves. Surgical technique was per the surgeon’s usual routine, as was the type of glove and use of single or double gloves. Use of latex-free gloves was also noted when these were worn by the surgeon. Gloves used by surgeons in the study were manufactured by 4 companies: Cardinal Health (Dublin, OH), Ansell (Iselin, NJ), Mölnlycke (Norcross, GA), and Medline (Mundelein, IL). In 47 cases, latex gloves were used (these were manufactured by either Medline or Ansell); the remainder were synthetic. For surgeons who double gloved, the same manufacturer made both pairs of gloves. Surgical cases were categorized as soft tissue only (ie, trigger finger release [TF], tendon repairs, ganglion excisions), nerve releases (ie, CTR and cubital tunnel releases), fracture surgery, reconstructive (ie, thumb basal joint arthroplasty, proximal row carpectomy, and arthrodesis), and arthroscopy. Table 1 summarizes the distribution of surgical case types. Because our data had a non-normal distribution, we calculated 95% confidence intervals and estimated sample size using a bootstrap method with an attempted 1,000 replications using SPSS statistical software (IBM, Armonk, NY).9 The bootstrap method models observations by assuming a variety of distributions. We performed 1,000 simulations to see whether these replications led to a different result
MATERIALS AND METHODS With institutional review board approval, we prospectively examined the rate of glove perforations among 10 hand surgery fellowship-trained orthopedic surgeons at our institution who performed consecutive elective surgery over a 6 week period. We J Hand Surg Am.
r
Vol. -, - 2017
1.e3
GLOVE PERFORATION
TABLE 1.
Distribution of Surgical Case Types Nerve
Soft Tissue
Fracture
Reconstructive
Arthroscopy
Combined
Other
Total
Cases, n
150
201
132
27
16
37
37
600
Total (%)
25
33
22
5
3
6
6
100
than that observed. Based on that analysis, and assuming the prevalence of 2.5%, our post hoc power analysis indicated that a sample of 600 was needed to provide an estimate with 1.25% precision.
is low. Most commonly, the surgeons in our study did not notice the hole in their gloves during the procedure. This was true even for surgeons who routinely wear a single glove. Based on studies reported in the general surgery and gynecology literature, use of double gloving is recommended by authors in these disciplines to decrease the risk of exposure to pathogens.10e13 Many studies across other disciplines examined the rates of glove perforation during surgery.10e24 Barbosa et al14 found a low rate (1%) after minor plastic surgery procedures but a higher rate (21%) during major procedures. Similarly, Cole and Gault13 found a 21.5% rate of holes during single-gloved plastic surgery procedures, which decreased to 9% with double gloving. In their study, the dorsal side of the nondominant hand was most commonly perforated. Rates of perforations in other studies varied from 8% to as high as 61%.17,18,21,24,25 Within the orthopedic surgery literature, rates of glove perforation were examined most commonly in general orthopedic or hip and knee arthroplasty procedures. In a review of 1,398 gloves used during general orthopedic procedures, Maffulli et al20 found a perforation rate of 26%. Demircay et al15 reported an 18.4% outer glove and 8.4% inner glove perforation rate. Most of their holes occurred in the nondominant index finger. Tao et al22 found a perforation rate of 12% in a review of hip arthroplasty procedures. In a study from over 20 years ago, Wright et al23 reported a perforation rate of 67% during hip arthroplasty closure using both standard and tapered point needles. The current study’s rate of glove perforation was lower than these reports, and much lower than the 19% reported in hand surgery by Maffulli et al,2 although this and many of the other reports were from the 1980s or 1990s. In the 1990s, largely in response to increasing rates of latex allergy and concerns regarding adverse effects of powder, glove makers developed techniques to manufacture powder-free latex gloves and to use synthetic alternatives to natural rubber latex.7,26 It may be that changes in the glove manufacturing process or glove material over the past few decades may be at least partly responsible for the decreased rate of glove
RESULTS Among the 10 surgeons, 6 routinely double gloved whereas 4 did not. There were 600 surgical procedures included during the study period. In 10 gloves there were 11 perforations (during a fracture case, 1 glove had 2 separate perforations). The perforation rate per case was 1.5% (95% confidence interval, 0.78% to 2.8%). Perforations occurred only within the fracture surgery and soft tissue categories. There were 4 gloves with holes (40% of all perforated gloves) that occurred during fracture surgery on the distal radius, olecranon, metacarpals, and scaphoid. Holes occurred in the remaining 6 gloves (60% of all perforated gloves) during isolated CTR (n ¼ 3) or combined CTR and TF release (n ¼ 3). In 2 gloves, the perforation was noticed intraoperatively (olecranon fracture and 1 TF). In the remaining gloves, the holes were not discovered until evaluation after the procedures. Two holes occurred in gloves of surgeons who wore single gloves. Neither were recognized intraoperatively. There were no cases in which the surgeon’s skin was broken. There were 2 holes in 283 cases performed by singlegloved physicians and 9 in 317 cases by doublegloved physicians. The difference in the perforation rate between single- and double-gloved procedures was not significant (P > .05). There were no holes in the inner gloves of surgeons who wore double gloves. Most perforations (8 of 11) occurred on the surgeon’s index finger. Seventy-five percent of these (6 of 8) occurred on the dominant hand. The dominant thumb, nondominant ring, and nondominant little fingers each had a single perforation. DISCUSSION Integrity of the surgical glove is important both for maintenance of sterility and to protect the surgeon. The findings of our study demonstrated that the rate of glove perforation during hand surgical procedures J Hand Surg Am.
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GLOVE PERFORATION
perforations in the current study compared with prior investigations. We did not expect that the cases in which we found glove perforations would include short soft tissue procedures. In the report by Maffulli et al,2 most of the recognized perforations occurred during suturing of the wound. Other investigators found a higher rate of holes in gloves used during laparoscopic cholecystectomy compared with open procedures.25 In addition, Giordano et al27 examined in an experimental model whether a 2-handed surgical knot-tying technique was likely to cause glove perforations. After examining 150 pairs of gloves, each of which was used to throw 5 surgical knots, no holes were discovered. We would have liked to have identified at-risk procedures, but given the low rate of perforation, this was not feasible. We did not include urgent or emergent trauma cases. It is possible that the rate of perforations during these procedures would have differed from what we found in elective or semielective cases. Also, because of the variety of glove types used and the low rate of perforations, we are not able to conclude whether any particular glove type is more or less susceptible to perforation. It is possible that some gloves are stronger or more resistant to perforation than others. However, the use of multiple glove types makes our results more generalizable. Goldman et al3 examined surgical gloves that had been caught in rotary instruments (ie, drills and reamers) during surgery. They discovered that 52% of 33 gloves that had been caught in 1 of these instruments had a perforation. Although we expected that holes might occur during bony work or fracture surgery because of the power instruments and the potentially jagged nature of bone, we did not anticipate that such a large proportion of holes would develop during relatively short soft tissue procedures. There are several limitations to our study. First, although we tried to standardize our technique for testing the gloves, we were not able to ensure that exactly the same amount of water was used or that the pressure applied by the tester was uniform. Nevertheless, this is an established model of hole detection in the literature, and one that was reproducible. Second, we were not able to establish a baseline level of glove defects. The American Society for Testing and Materials standard for medical glove testing is a 1.5% defect rate, and the glove manufacturers involved in the study indicated that their gloves met or exceeded these standards.28 We assume, and our study results demonstrated, that the baseline rate of defects is this rate or less. Finally, we J Hand Surg Am.
cannot conclude whether the presence of a tiny, imperceptible glove perforation during a hand surgical procedure is clinically relevant with regard to infection. We are not aware of any adverse events related to the perforations; however, our study did not specifically evaluate this. We are not aware of any literature that specifically links glove perforations and their impact on patients or surgeons. Fortunately, the rate of infection after hand surgical procedures is low despite the likely presence of these holes in some cases.29 Similarly, we did not measure the size of the holes detected, and cannot conclude whether there is a threshold hole size beyond which infection or disease transmission becomes more likely. Surgical glove perforation rates are low during hand surgical procedures. Gloves are vulnerable to perforation even for short soft tissue procedures. The rate of perforations is much lower than that reported previously, and surgeons can be reassured that this occurrence is rare. The most common location for a glove perforation in the current study was the dominant index finger; surgeons should be aware of this. The use of double gloves is at the discretion and comfort of the operating surgeon, but it appears to protect against exposure, because the inner gloves remained intact in surgeons who used 2 gloves. REFERENCES 1. Lathan SR. Caroline Hampton Halsted: the first to use rubber gloves in the operating room. Proc Bayl Univ Med Cent. 2010;23(4): 389e392. 2. Maffulli N, Testa V, Capasso G. Glove perforation in hand surgery. J Hand Surg Am. 1991;16(6):1034e1037. 3. Goldman AH, Haug E, Owen JR, Wayne JS, Golladay GJ. High risk of surgical glove perforation from surgical rotatory instruments. Clin Orthop Relat Res. 2016;474:2513e2517. 4. Koval KJ, Harrast JJ, Anglen JO, Weinstein JN. Fractures of the distal part of the radius: the evolution of practice over time. Where’s the evidence? J Bone Joint Surg Am. 2008;90(9):1855e1861. 5. Lutsky K, McKeon K, Goldfarb C, Boyer M. Dorsal fixation of intraarticular distal radius fractures using 2.4-mm locking plates. Tech Hand Up Extrem Surg. 2009;13(4):187e196. 6. Lalonde D, Eaton C, Amadio P, Jupiter J. Wide-awake hand and wrist surgery: a new horizon in outpatient surgery. Instr Course Lect. 2015;64:249e259. 7. Ansell Europe. Recent changes in natural rubber latex medical gloves and comparison with synthetic materials. Available at: http://www. anselleurope.com/ansell/media/links%20en/Ansell_position_paper. pdf. Accessed November 29, 2016. 8. McCue SF, Berg EW, Saunders EA. Efficacy of double-gloving as a barrier to microbial contamination during total joint arthroplasty. J Bone Joint Surg Am. 1981;63(5):811e813. 9. Naing L, Winn T, Rusli BN. Practical issues in calculating the sample size for prevalence studies. Arch Orofac Sci. 2006;1:9e14. 10. Aarnio P, Laine T. Glove perforation rate in vascular surgery—a comparison between single and double gloving. Vasa. 2001;30(2): 122e124.
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21. Murta EF, Silva CS, Junior OR. Frequency of glove perforation and the protective effect of double gloves in gynecological surgery. Arch Gynecol Obstet. 2003;268(2):82e84. 22. Tao LX, Basnet DK. Study of glove perforation during hip replacement arthroplasty: its frequency, location, and timing. Int Sch Res Notices. 2014 Oct 29;2014:129561. http://dx.doi.org/10.1155/ 2014/129561. 23. Wright KU, Moran CG, Briggs PJ. Glove perforation during hip arthroplasty: a randomised prospective study of a new taperpoint needle. J Bone Joint Surg Br. 1993;75(6):918e920. 24. Xavier RL, Vasconcelos BC, da Silva LC, Porto GG. Glove perforation during oral surgical procedures. Med Oral Patol Oral Cir Bucal. 2006;11(5):E433eE436. 25. Walczak DA, Zakrzewski J, Pawelczak D, Grobelski B, Pasieka Z. Evaluation of surgical glove perforation after laparoscopic and open cholecystectomy. Acta Chir Belg. 2013;113(6):423e428. 26. Deroian E, Moss R, Pfister JI, Kneedler JA. Powdered surgical gloves: is it time for a change? Available at: http://www.pfiedler.com/ ce/1289/files/assets/common/downloads/Powdered%20surgical% 20gloves.pdf. Accessed November 29, 2016. 27. Giordano V, Koch HA, de Sousa Prado J, et al. Is the surgical knot tying technique associated with a risk for unnoticed glove perforation? An experimental study. Patient Saf Surg. 2014;8:26. 28. Cardinal Health. Protexis PI Micro Surgical Gloves. Available at: http://www.cardinalhealth.com/content/dam/corp/web/documents/ Sellsheet/CardinalHealth-Protexis-PI-Micro-Surgical-GlovesLiterature.pdf. Accessed November 29, 2016. 29. Tosti R, Fowler J, Dwyer J, Maltenfort M, Thoder JJ, Ilyas AM. Is antibiotic prophylaxis necessary in elective soft tissue hand surgery? Orthopedics. 2012;35:e829ee833.
11. Punyatanasakchai P, Chittacharoen A, Ayudhya NI. Randomized controlled trial of glove perforation in single- and double-gloving in episiotomy repair after vaginal delivery. J Obstet Gynaecol Res. 2004;30(5):354e357. 12. Thomas S, Agarwal M, Mehta G. Intraoperative glove perforation— single versus double gloving in protection against skin contamination. Postgrad Med J. 2001;77(909):458e460. 13. Cole RP, Gault DT. Glove perforation during plastic surgery. Br J Plast Surg. 1989;42(4):481e483. 14. Barbosa MV, Nahas FX, Ferreira LM, Farah AB, Ayaviri NA, Bariani RL. Risk of glove perforation in minor and major plastic surgery procedures. Aesthetic Plast Surg. 2003;27(6): 481e484. 15. Demircay E, Unay K, Bilgili MG, Alataca G. Glove perforation in hip and knee arthroplasty. J Orthop Sci. 2010;15(6): 790e794. 16. Dodds RD, Guy PJ, Peacock AM, Duffy SR, Barker SG, Thomas MH. Surgical glove perforation. Br J Surg. 1988;75(10): 966e968. 17. Driever R, Beie M, Schmitz E, et al. Surgical glove perforation in cardiac surgery. Thorac Cardiovasc Surg. 2001;49(6):328e330. 18. Hollaus PH, Lax F, Janakiev D, Wurnig PN, Pridun NS. Glove perforation rate in open lung surgery. Eur J Cardiothorac Surg. 1999;15(4):461e464. 19. Kaya I, Ugras A, Sungur I, Yilmaz M, Korkmaz M, Cetinus E. Glove perforation time and frequency in total hip arthroplasty procedures. Acta Orthop Traumatol Turc. 2012;46(1):57e60. 20. Maffulli N, Capasso G, Testa V. Glove perforation in elective orthopedic surgery. Acta Orthop Scand. 1989;60(5):565e566.
J Hand Surg Am.
1.e5
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Incidence of Glove Perforation During Hand Surgical Procedures Kevin F. Lutsky, MD,* Christopher Jones, MD,* Jack Abboudi, MD,* William Kirkpatrick, MD,* Fred Liss, MD,* Charles Leinberry, MD,* Asif Ilyas, MD,* Dennis Martin, MS,* Pedro K. Beredjiklian, MD*
Purpose To determine the rate of glove perforation during hand surgery. Methods We prospectively examined the rate of glove perforations among 10 fellowshiptrained hand surgeons at our institution during a 6 week period. Gloves were tested for perforation using a water-fill technique at the conclusion of each surgical procedure. Surgeons recorded the presence of any glove perforations. Results Eleven perforations were identified in 10 gloves among 600 surgical procedures during the study period. The perforation rate per case was 1.5% (95% confidence interval, 0.78% to 2.8%). Forty percent of perforations (n ¼ 4) occurred during fracture surgery. Other holes occurred during isolated carpal tunnel release (n ¼ 3) or combined carpal tunnel and trigger finger release (n ¼ 3). The perforation was noticed intraoperatively in only 2 gloves. The difference in perforation rate between single- and double-gloved procedures was not significant. There were no perforations in the inner glove of surgeons who double gloved. A total of 73% of holes (8 of 11) occurred on surgeons’ index finger; 75% of these were on the dominant hand. The dominant thumb, non-dominant ring and nondominant little fingers each had a single perforation. Conclusions The rate of glove perforation during hand surgery is low. Holes can occur even during soft tissue procedures of short duration. The dominant index finger appears to be at greatest risk for perforation. When they do occur, most often holes are not noticed by the operating surgeon. The baseline glove perforation rate is unknown. Clinical relevance A high level of vigilance is required to maintain sterile technique. (J Hand Surg Am. 2017;-(-):1.e1-e5. Copyright Ó 2017 by the American Society for Surgery of the Hand. All rights reserved.) Key words Glove perforation.
T
to the late 19th century. Caroline Hampton, the scrub nurse in the operating room of William Stewart Halsted, developed contact dermatitis in her hands from phenol and mercuric chloride, commonly HE USE OF SURGICAL GLOVES DATES
From *Hand and Upper Extremity Surgery, The Rothman Institute, 925 Chestnut Street, Philadelphia, PA. Received for publication December 22, 2016; accepted in revised form June 28, 2017. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article.
used as surgical disinfectants. To address the problem, Dr. Halsted, chief of surgery at Johns Hopkins Hospital, commissioned the Goodyear Rubber Company to create thin rubber gloves to protect his nurse. The use of surgical gloves became commonplace among Corresponding author: Kevin F. Lutsky, MD, Hand and Upper Extremity Surgery, The Rothman Institute, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107; e-mail: Kevin. [email protected]. 0363-5023/17/---0001$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2017.06.103
Ó 2017 ASSH
r
Published by Elsevier, Inc. All rights reserved.
r
1.e1
1.e2
GLOVE PERFORATION
other nurses, and eventually surgeons adopted the practice. Joseph Bloodgood, one of Dr. Halsted’s protégés, reported a near 100% drop in infection rate in over 450 hernia surgeries with the use of gloves in 1899. In light of this success, Dr. Halsted and many of his contemporaries adopted the routine use of gloves during surgical procedures.1 For the hands of the surgeon, the surgical glove provides a barrier to isolate the skin surface of the surgical team from the patient. Glove perforation results in a break in this barrier, which can potentially result in wound contamination and expose the surgeon and patient to pathogens. In 1991, Maffulli et al2 examined the rate of latex glove perforation in hand surgical cases and found a rate of 19%. Most of these perforations were not detected by the operating surgeon during the procedure. This rate of glove perforation seems high, given that our anecdotal experience suggested that glove perforations are rare during hand surgery. However, based on the experience of Maffulli et al and others,3 holes may occur much more frequently than we are aware, and even close intraoperative inspection of a potentially compromised glove may be inadequate to detect a perforation. Surgical practice has changed considerably since the report of Maffulli et al2 nearly 25 years ago. Procedures such as volar plating of distal radius fractures have become far more common4 whereas implants have become more refined with features including smooth, tapered edges and precontours5 that may be less likely to cause perforations. Many surgeons have adopted wide-awake local anesthesia with no tourniquet, which can result in a bloodier surgical field.6 Many surgical procedures such as carpal tunnel release (CTR) and cubital tunnel release are being performed through more minimally invasive and/or endoscopic approaches, and glove manufacturing techniques and quality control measures have been modified over the past quarter century.7 Therefore, the purpose of our study was to evaluate the rate of surgical glove perforation during common hand surgical procedures. We hypothesized that these changes would result overall in a lower rate of glove perforation than previously reported.
believed that excluding trauma patients would eliminate some degree of variability, because these surgeries are often performed at off hours, with an unfamiliar team, and in an uncontrolled setting. During this time, surgeons recorded the presence of any glove perforations noted during the surgical procedure. If a perforation was noticed during the procedure, the location (side, digit, and outer/inner glove) was recorded. If no perforation was noted during the procedure, the surgeon tested each of the outer and inner gloves for perforations at the conclusion of surgery. The method used to detect holes was a water-fill technique identical to that used by Maffulli et al2 and described by McCue et al,8 which is validated for determining holes equivalent to the size of a 26gauge needle and larger. Each glove was overfilled with water and then squeezed, both at the base of the glove to pressurize the palm and along each digit. A perforation was noted as a stream of water. For surgeons who used double gloves, the same analysis was performed for both the inner and outer gloves. The gloves of surgical assistants were not tested. Surgeons also recorded the following variables: type of procedure, type of anesthesia, surgical or tourniquet time, glove type, and use of single or double gloves. Surgical technique was per the surgeon’s usual routine, as was the type of glove and use of single or double gloves. Use of latex-free gloves was also noted when these were worn by the surgeon. Gloves used by surgeons in the study were manufactured by 4 companies: Cardinal Health (Dublin, OH), Ansell (Iselin, NJ), Mölnlycke (Norcross, GA), and Medline (Mundelein, IL). In 47 cases, latex gloves were used (these were manufactured by either Medline or Ansell); the remainder were synthetic. For surgeons who double gloved, the same manufacturer made both pairs of gloves. Surgical cases were categorized as soft tissue only (ie, trigger finger release [TF], tendon repairs, ganglion excisions), nerve releases (ie, CTR and cubital tunnel releases), fracture surgery, reconstructive (ie, thumb basal joint arthroplasty, proximal row carpectomy, and arthrodesis), and arthroscopy. Table 1 summarizes the distribution of surgical case types. Because our data had a non-normal distribution, we calculated 95% confidence intervals and estimated sample size using a bootstrap method with an attempted 1,000 replications using SPSS statistical software (IBM, Armonk, NY).9 The bootstrap method models observations by assuming a variety of distributions. We performed 1,000 simulations to see whether these replications led to a different result
MATERIALS AND METHODS With institutional review board approval, we prospectively examined the rate of glove perforations among 10 hand surgery fellowship-trained orthopedic surgeons at our institution who performed consecutive elective surgery over a 6 week period. We J Hand Surg Am.
r
Vol. -, - 2017
1.e3
GLOVE PERFORATION
TABLE 1.
Distribution of Surgical Case Types Nerve
Soft Tissue
Fracture
Reconstructive
Arthroscopy
Combined
Other
Total
Cases, n
150
201
132
27
16
37
37
600
Total (%)
25
33
22
5
3
6
6
100
than that observed. Based on that analysis, and assuming the prevalence of 2.5%, our post hoc power analysis indicated that a sample of 600 was needed to provide an estimate with 1.25% precision.
is low. Most commonly, the surgeons in our study did not notice the hole in their gloves during the procedure. This was true even for surgeons who routinely wear a single glove. Based on studies reported in the general surgery and gynecology literature, use of double gloving is recommended by authors in these disciplines to decrease the risk of exposure to pathogens.10e13 Many studies across other disciplines examined the rates of glove perforation during surgery.10e24 Barbosa et al14 found a low rate (1%) after minor plastic surgery procedures but a higher rate (21%) during major procedures. Similarly, Cole and Gault13 found a 21.5% rate of holes during single-gloved plastic surgery procedures, which decreased to 9% with double gloving. In their study, the dorsal side of the nondominant hand was most commonly perforated. Rates of perforations in other studies varied from 8% to as high as 61%.17,18,21,24,25 Within the orthopedic surgery literature, rates of glove perforation were examined most commonly in general orthopedic or hip and knee arthroplasty procedures. In a review of 1,398 gloves used during general orthopedic procedures, Maffulli et al20 found a perforation rate of 26%. Demircay et al15 reported an 18.4% outer glove and 8.4% inner glove perforation rate. Most of their holes occurred in the nondominant index finger. Tao et al22 found a perforation rate of 12% in a review of hip arthroplasty procedures. In a study from over 20 years ago, Wright et al23 reported a perforation rate of 67% during hip arthroplasty closure using both standard and tapered point needles. The current study’s rate of glove perforation was lower than these reports, and much lower than the 19% reported in hand surgery by Maffulli et al,2 although this and many of the other reports were from the 1980s or 1990s. In the 1990s, largely in response to increasing rates of latex allergy and concerns regarding adverse effects of powder, glove makers developed techniques to manufacture powder-free latex gloves and to use synthetic alternatives to natural rubber latex.7,26 It may be that changes in the glove manufacturing process or glove material over the past few decades may be at least partly responsible for the decreased rate of glove
RESULTS Among the 10 surgeons, 6 routinely double gloved whereas 4 did not. There were 600 surgical procedures included during the study period. In 10 gloves there were 11 perforations (during a fracture case, 1 glove had 2 separate perforations). The perforation rate per case was 1.5% (95% confidence interval, 0.78% to 2.8%). Perforations occurred only within the fracture surgery and soft tissue categories. There were 4 gloves with holes (40% of all perforated gloves) that occurred during fracture surgery on the distal radius, olecranon, metacarpals, and scaphoid. Holes occurred in the remaining 6 gloves (60% of all perforated gloves) during isolated CTR (n ¼ 3) or combined CTR and TF release (n ¼ 3). In 2 gloves, the perforation was noticed intraoperatively (olecranon fracture and 1 TF). In the remaining gloves, the holes were not discovered until evaluation after the procedures. Two holes occurred in gloves of surgeons who wore single gloves. Neither were recognized intraoperatively. There were no cases in which the surgeon’s skin was broken. There were 2 holes in 283 cases performed by singlegloved physicians and 9 in 317 cases by doublegloved physicians. The difference in the perforation rate between single- and double-gloved procedures was not significant (P > .05). There were no holes in the inner gloves of surgeons who wore double gloves. Most perforations (8 of 11) occurred on the surgeon’s index finger. Seventy-five percent of these (6 of 8) occurred on the dominant hand. The dominant thumb, nondominant ring, and nondominant little fingers each had a single perforation. DISCUSSION Integrity of the surgical glove is important both for maintenance of sterility and to protect the surgeon. The findings of our study demonstrated that the rate of glove perforation during hand surgical procedures J Hand Surg Am.
r
Vol. -, - 2017
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perforations in the current study compared with prior investigations. We did not expect that the cases in which we found glove perforations would include short soft tissue procedures. In the report by Maffulli et al,2 most of the recognized perforations occurred during suturing of the wound. Other investigators found a higher rate of holes in gloves used during laparoscopic cholecystectomy compared with open procedures.25 In addition, Giordano et al27 examined in an experimental model whether a 2-handed surgical knot-tying technique was likely to cause glove perforations. After examining 150 pairs of gloves, each of which was used to throw 5 surgical knots, no holes were discovered. We would have liked to have identified at-risk procedures, but given the low rate of perforation, this was not feasible. We did not include urgent or emergent trauma cases. It is possible that the rate of perforations during these procedures would have differed from what we found in elective or semielective cases. Also, because of the variety of glove types used and the low rate of perforations, we are not able to conclude whether any particular glove type is more or less susceptible to perforation. It is possible that some gloves are stronger or more resistant to perforation than others. However, the use of multiple glove types makes our results more generalizable. Goldman et al3 examined surgical gloves that had been caught in rotary instruments (ie, drills and reamers) during surgery. They discovered that 52% of 33 gloves that had been caught in 1 of these instruments had a perforation. Although we expected that holes might occur during bony work or fracture surgery because of the power instruments and the potentially jagged nature of bone, we did not anticipate that such a large proportion of holes would develop during relatively short soft tissue procedures. There are several limitations to our study. First, although we tried to standardize our technique for testing the gloves, we were not able to ensure that exactly the same amount of water was used or that the pressure applied by the tester was uniform. Nevertheless, this is an established model of hole detection in the literature, and one that was reproducible. Second, we were not able to establish a baseline level of glove defects. The American Society for Testing and Materials standard for medical glove testing is a 1.5% defect rate, and the glove manufacturers involved in the study indicated that their gloves met or exceeded these standards.28 We assume, and our study results demonstrated, that the baseline rate of defects is this rate or less. Finally, we J Hand Surg Am.
cannot conclude whether the presence of a tiny, imperceptible glove perforation during a hand surgical procedure is clinically relevant with regard to infection. We are not aware of any adverse events related to the perforations; however, our study did not specifically evaluate this. We are not aware of any literature that specifically links glove perforations and their impact on patients or surgeons. Fortunately, the rate of infection after hand surgical procedures is low despite the likely presence of these holes in some cases.29 Similarly, we did not measure the size of the holes detected, and cannot conclude whether there is a threshold hole size beyond which infection or disease transmission becomes more likely. Surgical glove perforation rates are low during hand surgical procedures. Gloves are vulnerable to perforation even for short soft tissue procedures. The rate of perforations is much lower than that reported previously, and surgeons can be reassured that this occurrence is rare. The most common location for a glove perforation in the current study was the dominant index finger; surgeons should be aware of this. The use of double gloves is at the discretion and comfort of the operating surgeon, but it appears to protect against exposure, because the inner gloves remained intact in surgeons who used 2 gloves. REFERENCES 1. Lathan SR. Caroline Hampton Halsted: the first to use rubber gloves in the operating room. Proc Bayl Univ Med Cent. 2010;23(4): 389e392. 2. Maffulli N, Testa V, Capasso G. Glove perforation in hand surgery. J Hand Surg Am. 1991;16(6):1034e1037. 3. Goldman AH, Haug E, Owen JR, Wayne JS, Golladay GJ. High risk of surgical glove perforation from surgical rotatory instruments. Clin Orthop Relat Res. 2016;474:2513e2517. 4. Koval KJ, Harrast JJ, Anglen JO, Weinstein JN. Fractures of the distal part of the radius: the evolution of practice over time. Where’s the evidence? J Bone Joint Surg Am. 2008;90(9):1855e1861. 5. Lutsky K, McKeon K, Goldfarb C, Boyer M. Dorsal fixation of intraarticular distal radius fractures using 2.4-mm locking plates. Tech Hand Up Extrem Surg. 2009;13(4):187e196. 6. Lalonde D, Eaton C, Amadio P, Jupiter J. Wide-awake hand and wrist surgery: a new horizon in outpatient surgery. Instr Course Lect. 2015;64:249e259. 7. Ansell Europe. Recent changes in natural rubber latex medical gloves and comparison with synthetic materials. Available at: http://www. anselleurope.com/ansell/media/links%20en/Ansell_position_paper. pdf. Accessed November 29, 2016. 8. McCue SF, Berg EW, Saunders EA. Efficacy of double-gloving as a barrier to microbial contamination during total joint arthroplasty. J Bone Joint Surg Am. 1981;63(5):811e813. 9. Naing L, Winn T, Rusli BN. Practical issues in calculating the sample size for prevalence studies. Arch Orofac Sci. 2006;1:9e14. 10. Aarnio P, Laine T. Glove perforation rate in vascular surgery—a comparison between single and double gloving. Vasa. 2001;30(2): 122e124.
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21. Murta EF, Silva CS, Junior OR. Frequency of glove perforation and the protective effect of double gloves in gynecological surgery. Arch Gynecol Obstet. 2003;268(2):82e84. 22. Tao LX, Basnet DK. Study of glove perforation during hip replacement arthroplasty: its frequency, location, and timing. Int Sch Res Notices. 2014 Oct 29;2014:129561. http://dx.doi.org/10.1155/ 2014/129561. 23. Wright KU, Moran CG, Briggs PJ. Glove perforation during hip arthroplasty: a randomised prospective study of a new taperpoint needle. J Bone Joint Surg Br. 1993;75(6):918e920. 24. Xavier RL, Vasconcelos BC, da Silva LC, Porto GG. Glove perforation during oral surgical procedures. Med Oral Patol Oral Cir Bucal. 2006;11(5):E433eE436. 25. Walczak DA, Zakrzewski J, Pawelczak D, Grobelski B, Pasieka Z. Evaluation of surgical glove perforation after laparoscopic and open cholecystectomy. Acta Chir Belg. 2013;113(6):423e428. 26. Deroian E, Moss R, Pfister JI, Kneedler JA. Powdered surgical gloves: is it time for a change? Available at: http://www.pfiedler.com/ ce/1289/files/assets/common/downloads/Powdered%20surgical% 20gloves.pdf. Accessed November 29, 2016. 27. Giordano V, Koch HA, de Sousa Prado J, et al. Is the surgical knot tying technique associated with a risk for unnoticed glove perforation? An experimental study. Patient Saf Surg. 2014;8:26. 28. Cardinal Health. Protexis PI Micro Surgical Gloves. Available at: http://www.cardinalhealth.com/content/dam/corp/web/documents/ Sellsheet/CardinalHealth-Protexis-PI-Micro-Surgical-GlovesLiterature.pdf. Accessed November 29, 2016. 29. Tosti R, Fowler J, Dwyer J, Maltenfort M, Thoder JJ, Ilyas AM. Is antibiotic prophylaxis necessary in elective soft tissue hand surgery? Orthopedics. 2012;35:e829ee833.
11. Punyatanasakchai P, Chittacharoen A, Ayudhya NI. Randomized controlled trial of glove perforation in single- and double-gloving in episiotomy repair after vaginal delivery. J Obstet Gynaecol Res. 2004;30(5):354e357. 12. Thomas S, Agarwal M, Mehta G. Intraoperative glove perforation— single versus double gloving in protection against skin contamination. Postgrad Med J. 2001;77(909):458e460. 13. Cole RP, Gault DT. Glove perforation during plastic surgery. Br J Plast Surg. 1989;42(4):481e483. 14. Barbosa MV, Nahas FX, Ferreira LM, Farah AB, Ayaviri NA, Bariani RL. Risk of glove perforation in minor and major plastic surgery procedures. Aesthetic Plast Surg. 2003;27(6): 481e484. 15. Demircay E, Unay K, Bilgili MG, Alataca G. Glove perforation in hip and knee arthroplasty. J Orthop Sci. 2010;15(6): 790e794. 16. Dodds RD, Guy PJ, Peacock AM, Duffy SR, Barker SG, Thomas MH. Surgical glove perforation. Br J Surg. 1988;75(10): 966e968. 17. Driever R, Beie M, Schmitz E, et al. Surgical glove perforation in cardiac surgery. Thorac Cardiovasc Surg. 2001;49(6):328e330. 18. Hollaus PH, Lax F, Janakiev D, Wurnig PN, Pridun NS. Glove perforation rate in open lung surgery. Eur J Cardiothorac Surg. 1999;15(4):461e464. 19. Kaya I, Ugras A, Sungur I, Yilmaz M, Korkmaz M, Cetinus E. Glove perforation time and frequency in total hip arthroplasty procedures. Acta Orthop Traumatol Turc. 2012;46(1):57e60. 20. Maffulli N, Capasso G, Testa V. Glove perforation in elective orthopedic surgery. Acta Orthop Scand. 1989;60(5):565e566.
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