Abstract
Aim:
Since the introduction of surgical gloves, one of the main challenges has been to improve donning and wearability. For the wearer, the formation of “glove juice” is problematic. To improve gliding properties for donning the gloves and absorbing sweat, in 1963 Bio-sorb® cream: sterile powder cream (Johnson & Johnson Medical, Gargrave, Skipton, United Kingdom) was introduced. Individuals subjectively reported a reduction of sweat production inside the glove, however, the actual effect on sweat accumulation and surgical hand antisepsis has not been examined.
Methods:
Twenty-six volunteers were used in a study designed to examine the effect of a sterile hand cream applied after surgical hand antisepsis on sweat accumulation inside surgical gloves. A woven cotton glove was worn underneath the surgical glove. Weight differences were used to determine the amount of sweat produced. The influence of Bio-sorb on the efficacy of surgical hand antisepsis was tested immediately and after 90 minutes of wear time by the sampling technique as per EN 12791 and by bacterial analysis of glove juice according to tentative final monograph 1994.
Results and Discussion:
The amount of sweat produced inside the glove was not reduced by the cream (1.07 ± 0.5 g versus control 1.03 ± 0.5 g; p = 0.75). Considering different skin conditions, it may be possible that some wearers might subjectively observe decreased sweat production after using Bio-sorb cream before donning surgical gloves, because sweat production did decrease in 10 of 26 test subjects. Bio-sorb cream did not affect the efficacy of surgical hand antisepsis either immediately or after 90 minutes.
Conclusion:
Because of possible risks of contamination of the surgical site with cornstarch from Bio-sorb cream in the case of a glove breach and the failed statistical proof of reduced sweat production, the use of Bio-sorb cream should not to be recommended.
Gloves serve as a mechanical protective barrier between the surgeon's hand and the surgical site. A prospective observational cohort study showed the influence of glove perforation on the surgical site infection (SSI) rate after surgery without indication for antimicrobial prophylaxis [1]. During the 1980s, discussion around protective gloves gained new significance because of the emergence of human immunodeficiency virus (HIV), and for the first time, the prevention infection transmission from the patient to the healthcare worker became highly relevant. Thus, innovative antimicrobial glove technology was developed in order to reduce microbial passage across surgical gloves after puncture [2].
Since the introduction of surgical gloves, one of the main challenges has been to improve donning and wearability. The lubricant Bio-sorb® was developed and used for decades by surgeons worldwide. Interestingly, although Bio-sorb was not developed for that primary purpose, the wearers reported the perception of reduced sweat production. On the basis of the results of the present study, we requested information on the distribution of the product; Biosorb is no longer distributed by the manufacturer under its initial name yet is still available under various online distributors such as Amazon (www.amazon.de/Johnson-Cornstarch-Vitamin-Babypflege-Körperpflege/dp/B0009STDJW; accessed on August 3, 2019), under the brand name Johnson's Baby Powder Pure Cornstarch with or without aloe and vitamin E as a body creme for infants.
The following facts should be critically evaluated in this context. In 1963, the original inventor and distributor, Ethicon, a Johnson & Johnson company, introduced the lubricant Bio-sorb, a cream that was intended to replace the common procedure of powdering hands before donning gloves [3]. The manufacturer claimed Bio-sorb would reduce the risk of airborne infection, distribute a uniform lubricant film on all hand surfaces, overcome excess moisture (thus reducing the need for re-powdering between glove changes), and leave hands smooth because of its rapidly evaporating base. However, there is neither a published study to support the claimed sweat-reducing effect, nor other possible advantages for the use of Bio-sorb. This shows that it is possible to distribute an untested product for decades and highlights the importance of requiring investigation and proof of specific product claims before market introduction with objective scientific analysis, even when dealing with non-medical drug products. Additionally, it should have been determined that the use of Bio-sorb has no influence on the re-colonization of the skin after surgical hand antisepsis.
Bio-sorb cream contains cornstarch, ethanol, carbopol, and polyoxyethylene-(1.5)-cocoalkylamine. Ethanol forms the base of the emulsion, and upon evaporation it allows quick drying of the hands after application of Bio-sorb cream. Carbopol, a polyacrylic acid, is used as a super absorbent. Through absorption of water molecules from the hands, a hydrogel is created [4]. Polyoxyethylene-(1.5)-cocoalkylamine is used in the production of cosmetics as an emulsifier or plasticizer. The starch remains on the surface of the dried hands and inhibits adhesion.
Because some users subjectively reported less sweat formation under the surgical glove while using Bio-sorb cream prior to donning sterile gloves, we were interested in examining whether reduced sweat production can be objectified. Reduced sweat production would also reduce moisture exposure of the skin under the surgical glove, which could lead to a reduced risk of developing skin damage and delayed recolonization of the skin with microorganisms. For this reason, an additional question was to investigate the possible influence of Bio-sorb cream on the sustained (90 minute) effect of surgical hand antisepsis.
Methods
Study design
The influence of Bio-sorb on sweat production and efficacy of surgical hand antisepsis was analyzed using a study with randomized allocation to the test condition and hand (left and right hands). For this purpose, two groups of volunteers with 13 test subjects (five males and eight females per group, ages 21 to 35 years) were formed. Criteria for exclusion were injuries or diseases of the skin of the hands, and hand antisepsis within the last 48 hours prior to the tests. Criteria for inclusion were short, clean fingernails and absence of jewelry. The test subjects wore only a sterile surgical glove on one hand and a woven cotton glove below the sterile surgical glove on the other hand. The assignment to the group and the selection of hand (right or left) for application of Bio-sorb in combination with the woven cotton glove was randomly assigned. During the first round, group 1 used Bio-sorb cream (one pack per person, 1.75 g, spread over the hands for 15 seconds) after surgical hand antisepsis, whereas group 2 only performed the surgical antisepsis procedure. After a free period of seven days, the procedure was repeated, however, this time on the respective other hand. Between the first and second step of the experiments, hand antisepsis was not allowed. The efficacy of hand antisepsis was tested in the group with Bio-sorb application on this hand to compare the efficacy in the group without Bio-sorb application. All tests were done within two weeks in May and June.
Exclusion of antimicrobial inhibition by Bio-sorb and the woven cotton glove
Preliminary test runs were used to rule out Bio-sorb cream and the woven cotton glove had intrinsic antimicrobial properties. For the test of Bio-sorb cream, two blood agar plates each were inoculated with Staphylococcus epidermidis (ATCC 12228), Staphylococcus aureus (ATCC 6538), or Escherichia coli (ATCC 25922). Five holes with a diameter of 10 mm were stamped into each plate filled with 0.5 g Bio-sorb cream each. Afterwards, the plates were incubated for 24 hours at 36° ± 1°C.
For the examination of the woven cotton gloves, one blood agar plate each was inoculated with the same strains, and four 10 × 10 mm pieces of the glove were placed on each plate. Plates were incubated at 36° ± 1°C for 24 hours.
Measurement of amount of sweat
The last hand washing had to be done one hour prior to the start of the test, and the use of hand cream was prohibited on the day of the test. To determine the amount of sweat after 90 minutes of glove wearing, the woven cotton gloves worn on the left hand of participants (n = 26) were weighed before and after wearing. To obtain comparable values, the test subjects kneaded a soft foam ball alternately in both hands over the 90 minutes. The woven cotton glove was placed in an air- and water-tight polyethylene bag immediately after taking it off to prevent any loss of water. To eliminate evaporation effects until analysis, air pockets were squeezed out of the transport bag and the bag was hermetically sealed. After defined moistening of the glove with 1 mL of water (1 g) and one hour storage in the polyethylene bag, no water loss was detectable (below 2.5 mg). After opening the transport bag in the laboratory (transport time approximately 30 minutes), the woven cotton glove was transferred to a previously weighed beaker using forceps, and the weight difference was measured. Afterwards, the glove was dried in a drying chamber for two hours at 100°C and weighed again. The weight difference between the moist and dried condition defines the water percentage of sweat transferred from the surgical glove to the woven cotton glove. To create comparable ambient conditions, all test subjects had to stay in the same room while the gloves were worn. The procedure was repeated then on the respective other hand at the same time of day (in the morning).
Influence on the efficacy of surgical hand antisepsis
The basic procedure of surgical hand antisepsis was followed in accordance with EN 12791 [5]. Only the times were changed (see Discussion). After a 15-second hand wash with 5 mL Sapo kalinus, the following steps were performed: hands were rinsed with running tap water, dried with a sterile paper towel, and the pre-values were determined by rubbing the fingertips, including thumbs, of both hands for one minute in tryptic soy broth plus neutralizer (3% Tween 80, 3% saponin, 0.1% histidine, and 0.1% cystine). The hands were then air-dried for 10 minutes, followed by 90-second surgical hand antisepsis with 5 mL hand rub. In the pretest, we found that in every case 5 mL was enough to wet the hands completely. The immediate post-values of both hands were determined in the same manner. Thereafter, the following steps were carried out:
Application of Bio-sorb cream on both hands for half of the volunteers for 15 seconds. Application of a sterile surgical glove on one hand; application of a sterile woven cotton glove on the other hand, and covering with an additional sterile surgical glove (cotton gloves plus surgical gloves). Gloves were worn on both hands for 90 minutes.
On hands with surgical gloves, the 90-minute post-values were determined for the entire hand (glove juice method following TFM 1994 [6]). To determine the total bacterial load, the surgical glove was filled with 75 mL of sodium chloride solution containing the neutralizer while still being worn. While filling the glove, care was taken that the solution never touched the wrist, but instead ran straight into the glove. The glove was closed with a tourniquet around the ulnar caput and test subjects were asked to move their hand inside the glove for approximately one minute to let the sodium chloride solution rinse the entire hand. Afterwards, the glove was taken off and placed in a beaker, and the glove cuffs were pulled around the edge of the container. The solution from the glove was immediately decanted into a sterile tube. On hands with cotton gloves plus surgical gloves after taking off both gloves, the 90-minute post-values were determined by the sampling technique for pre- and immediate post-values.
The time period between sample collection and plating was 30 minutes at most. Cultivation and calculation of pre- and post-values followed EN 12791 [5]. Incubation was carried out for 24 hours at 36° ± 1°C. For each volunteer, the logarithmic reduction factor (RF) was obtained as the difference between the log10 pre-value and log10 post-values. The study was approved by the Ethics Committee of the University Hospital of Greifswald (Reg. No. BB 18/12).
Materials
The following materials were used: Bio-sorb cream: sterile powder cream, applied after hand antisepsis (Johnson & Johnson Medical, Gargrave, Skipton, UK; Ch.-No. 0921 – 03; ingredients: corn starch, ethanol, polyoxyethylene-(1.5)-cocoalkylamine, carbopol); hand disinfectant: AHD 2000 (Lysoform Dr. Hans Rosemann GmbH, Berlin, Germany; 77% w/w ethanol); surgical glove: Gammex® PF (Ansell GmbH, Munich, Germany, powder-free natural latex; and sterilized woven cotton glove: Peha-tex (Hartmann GmbH, Hainichen, Germany).
Statistics
Statistical analysis was performed using SPSS version 10.0 (SPSS Inc., Chicago, IL) for Windows XP. Data were presented as means ± standard deviations. Because the hypothesis was that Bio-sorb would cause a substantial reduction in sweat, differences were tested using the two-tailed Wilcoxon matched pairs signed-rank test as specified in EN 12791. Statistical significance was set at p < 0.05. In addition, the confidence intervals were used to compare the means. Because the hypothesis for the efficacy of surgical antisepsis was that there would be no statistically significant difference with and without use of Bio-sorb, differences in the immediate and long-term effects were tested using the non-parametric Hodges-Lehmann estimator [5].
Results
Intrinsic antimicrobial property of Bio-sorb and the woven cotton glove
Instead of a zone of inhibition, increased colony growth was induced next to the punched holes. Furthermore, the woven cotton glove induced no inhibition under or around the glove pieces placed on agar.
Amount of sweat
The amount of produced sweat was not affected by the use of Bio-sorb cream (1.07 + 0.5 g vs control 1.03 + 0.5 g; p = 0.75; n = 25). The difference to the data without the use of Bio-sorb cream was 0.036 ± 0.374 g, which indicates a trend toward higher sweat production, although 10 of 26 test subjects displayed lower sweat production after use of Bio-sorb cream (Table 1).
Amount of Sweat (g) after Use of Bio-sorb Cream
CI = confidence interval; SD = standard deviation.
Because the amount of sweat produced could also be related to other parameters that were not examined in this study, results were split for test subjects who either sweated more or less after use of Bio-sorb cream in total, and were then compared with groups with or without Bio-sorb cream use. The applied method did only allow comparing measurements after wearing gloves. Because a normal distribution could not be expected after this division of the results, confidence intervals were determined using a non-parametric procedure (Table 1). In the group of test subjects who produced more sweat after using Bio-sorb cream, the mean was 0.847 g for the control and 1.090 g for Bio-sorb cream. Because the two confidence intervals have considerable overlap, the difference was not statistically significant. In the group of test subjects who produced less sweat after use of Bio-sorb cream, the confidence interval was between 0.883 g and 1.719 g (mean = 1.301 g) after use of Bio-sorb cream, and between 0.883 g and 1.719 g for the control. The difference in this group was also not significant. It was, however, noticeable that the two confidence intervals of sweat amount in the control group have almost no overlap, so there might be a trend to less sweat production using Bio-sorb cream, even if it did not prove to be statistically significant. Because of the division of the test subjects and small sample sizes, all these results must be interpreted with caution.
Influence on surgical hand antisepsis
The evaluation of data obtained in accordance with EN 12791 [5] requires all means of logarithmized previous values to be at least 3.5. This prerequisite was met for all data sets. For the immediate effect, the mean logarithmic RF after using Bio-sorb is slightly higher compared with the RF without the use of Bio-sorb, but the influence of Bio-sorb was considered non-inferior to the reference product in the Hodges-Lehman test (p = 0.025, agreed inferiority margin = 0.75; calculated value = 0.25). The mean logarithmic RF after the use of Bio-sorb is slightly lower for the 90-minute effect compared with the reduction factor without Bio-sorb application (p = 0.025, agreed inferiority margin = 0.85; calculated value = 0.58). The mean logarithmic RF after the use of Bio-sorb is slightly lower for 90 minutes (whole hands) compared with the corresponding reduction factor without Bio-sorb (p = 0.025, agreed inferiority margin = 0.85; calculated value = 0.42).
The RF of the immediate effect did not differ between the two groups. The same applied for the RF after 90 minutes (Table 2). The post-values for the recovery of colony forming units (CFU) from fingertips as well as from the whole hand after application of Bio-sorb cream did not differ substantially from the value without Bio-sorb cream (Table 2).
Pre-Values Before Hand Antisepsis and Reduction Factors after Hand Antisepsis with and without Use of Bio-Sorb Cream (Non-Parametric Hodges-Lehmann Test)
RF = reduction factor.
Discussion
The study design was primarily chosen to exclude a difference between the right and left hand. The study did not aim to show differences between wearing surgical gloves and wearing surgical gloves plus woven cotton gloves.
To determine the influence of Bio-sorb on the efficacy of surgical hand antisepsis, we utilized kneading of the fingertips described in the sampling technique of EN 12791 [5]. Because Bio-sorb acts on the whole hand surface, we additionally determined the content of skin flora in glove juice. We selected 90 minutes as the wearing time for gloves, instead of three hours as requested in EN 12791 because the normal duration of operations in visceral surgery is approximately 90 minutes.
Contrary to EN 12791 [5], the test condition for hand washing was reduced from one minute to 15 seconds to not impede subsequent hand antisepsis [8]. This is a reasonable approach, as Weber et al. [7] showed that even 10 seconds are sufficient to reach a reduction of microbial counts. A washing duration of 30 or 60 seconds did not improve the results. For the same reason, we utilized a drying time of 10 minutes between hand washing and surgical hand antisepsis, because this duration is needed for normalization of hydration [8]. No exact standard could be established for the duration of spreading the Bio-sorb cream onto the hands, because the cream required different lengths of time between test subjects to dry properly. For this reason, the cream was applied until test subjects subjectively felt it dried, which took between 15 and 20 seconds.
It is possible that—depending on an individual's skin—a subjective impression could occur that sweat production was reduced after using Bio-sorb cream, because the trend for sweat production did decrease in 10 of 26 test subjects. However, because it increased for the other 16 test subjects no influence of the cream could be statistically proven. On the other hand, the efficacy of surgical hand antisepsis was not impaired after 90 minutes of wearing the gloves when using Bio-sorb cream. This poses the question of whether Bio-sorb cream use should depend on personal preference, because hand antisepsis is not impaired. However, the tolerability for possible Bio-sorb cream residue in the surgical incision must also be examined.
In the past, talcum powder was used, but because talcum granulomas after laparotomies were observed, it was gradually replaced by cornstarch during the 1940s. However, this change did lead not to the desired effect, because further granulomas were described after intra-peritoneal surgery when cornstarch was used. Clinical symptoms that appeared 10 days to four weeks after intra-peritoneal surgery included abdominal pain, vomiting, flatulence, low-grade fever, elevated leucocyte counts, and functional ileus [9–12]. After re-laparotomy, scattered nodules on the surface of the peritoneum, thickening of the omentum, ascites, and adhesions were described. Biopsies of the granuloma and ascites verified the presence of cornstarch [9–11].
At first, the presence of starch granuloma in women without preceding laparotomy was unexplained, but it was proven that the powder migrated into the peritoneum after vaginal examination [13]. Another complication of powder contamination is the development of adhesions [9,14–16]. Suspected causes for this are a foreign-body reaction, which leads to decreased fibrinolysis and consequent imbalance between fibrin deposition and degradation, as well as activation of leucocytes and release of different cytokines [12]. Problems caused by adhesions are the reason for 2% of inpatient treatment in general surgery [16]. Wound healing and scarring were also negatively influenced by the powder [12,17]. However, the use of gloves featuring a drying powder should not be automatically equated with the use of cornstarch in cream form, such as Bio-sorb cream, because the starch would be confined to the glove interior as long as it remained intact, and thus a contamination of the surgical area would be highly improbable. Because perforation of gloves occurred in up to 20% of the examined gloves used in visceral surgery [18,19], it must be assumed that a transmission of the starch from the surgeon's hands to the patient is possible.
The reduction of sweat production in surgical gloves is a hitherto unresolved issue. Even adding the antiperspirant aluminum chlorohydrate to 60% ethanol failed to achieve a substantial reduction in sweat production [20].
Limitations
As the main representative for alcoholic hand rubs, an ethanol-based product was used. In contrast to soaps, essential differences between the three possible short-chain alcohols is not to be expected, because the surface activity is equal. Our study has some further methodologically related limitations. In order to compare the effect of Bio-sorb correctly, which is applied to the entire hand, we had to sample the whole hand for sweat and bacterial colony forming units as well. Taking measurements from the fingertips only would not have represented the conditions found under clinical application. However, because of this, we could not calculate the difference between sweat and colony forming unit counts before and after application using the same methodology. Whereas for sweat production this aspect did not matter because hands were not sweaty before, this could have a theoretical effect on colony forming unit counts, resulting in lower counts for the fingertip method and higher counts for the whole-hand sampling. However, because of the highly insignificant differences, it cannot be expected that correcting for this limitation may have generated different results and conclusions. Furthermore, participants repeated the second measurement after seven days. We cannot rule out that other sweat-inducing factors such as stress or climate conditions may have influenced the results.
Conclusion
Because sweat production did not decrease, the use of Bio-sorb cream should not to be recommended. Additionally, possible risks of surgical site contamination with cornstarch from Bio-sorb cream in the case of glove breach also speaks against the Bio-sorb use.
Footnotes
Funding Information
No funding was received.
Author Disclosure Statement
All authors have no conflict of interest to declare.
