|Year : 2019 | Volume
| Issue : 1 | Page : 51-54
Reducing needlestick injuries in the operating room: Efficacy of wound closure with operative Armour™ as compared with traditional methods
Sneha Rao1, Eliana Saltzman1, Daniel Scott1, Sandra Au2, Selene Parekh3
1 Department of Orthopaedic Surgery, Duke University Medical Center, Durham, North Carolina, USA
2 Duke University School of Medicine, Duke University Medical Center, Durham, North Carolina, USA
3 Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery, Duke University Medical Center, Durham, North Carolina, USA
|Date of Submission||12-Sep-2019|
|Date of Acceptance||05-Oct-2019|
|Date of Web Publication||28-Feb-2020|
Dr. Eliana Saltzman
Department of Orthopaedic Surgery, Duke University Medical Center, Box 3000, Durham, NC 27710
Source of Support: None, Conflict of Interest: None
Introduction: Sharp injuries continue to pose a significant safety issue in the clinical setting with 385,000 injuries occurring annually among the United States health-care workers. In the operating room (OR), a majority of the needlestick injuries are due to frequent passing of contaminated needles. Operative Armour™ is a novel arm guard enabling surgeons to independently self-secure and self-dispose needles. We hypothesized that the use of Operative Armour™ as compared to the standard technique of sequentially passed needles would reduce the number of sutures passes.
Methods: A 12 cm incision was made through an anterior and posterior approach to the ankle in three cadavers. In Group A (standard technique), 2-0 vicryl suture was used. In Group B (Operative Armour™), 2-0 vicryl suture packs, containing five sutures, were used. Three participants completed three trials for each group. Outcomes included wound closure time and the number of dropped and passed needles.
Results: Wound closure time for Group A was 16:35 ± 0.2 min and 16:33 ± 0.1 min for Group B (P > 0.05). No needles were dropped in either group. Suture passes averaged 52 ± 8.9 in Group A compared to 5.3 ± 0.7 in Group B (P < 0.05). There were 24 needle handoffs in Group A, while in Group B, only three suture packs were passed.
Conclusions: Use of the Operative Armour™compared to the standard technique demonstrated a statistically significant decreased number of suture passes but no change in total closure time. Given the large reduction in suture passes, the use of the Operative Armour™ could lead to a significant reduction in the number of needlesticks in the OR during wound closure.
Clinical Significance: Compared to current standard techniques, the use of Operative Armour™ could increase safety in the OR by decreasing the number of suture passes. By reducing the demands on the surgical technician, this device could also decrease OR turnaround time and enhance overall efficiency.
Keywords: Cohort study, infection, needle contamination, operative safety, safety, sharp injury
|How to cite this article:|
Rao S, Saltzman E, Scott D, Au S, Parekh S. Reducing needlestick injuries in the operating room: Efficacy of wound closure with operative Armour™ as compared with traditional methods. Duke Orthop J 2019;9:51-4
|How to cite this URL:|
Rao S, Saltzman E, Scott D, Au S, Parekh S. Reducing needlestick injuries in the operating room: Efficacy of wound closure with operative Armour™ as compared with traditional methods. Duke Orthop J [serial online] 2019 [cited 2021 Aug 3];9:51-4. Available from: https://www.dukeorthojournal.com/text.asp?2019/9/1/51/279434
| Introduction|| |
The Centers for Disease Control and Prevention (CDC) estimates that at least 385,000 sharp injuries occur annually among the United States (US) health-care workers, with higher estimates predicting 800,000 injuries. Given the prevalence of sharps within the operative and nonoperative settings, needlestick injuries pose a significant obstacle to ensuring the safety of both patients and medical personnel. Of the sharp injuries that occurred between 1993 and 2006, the majority, 60.4%, are caused by nonhollow bore needles such as suture needles or scalpel blades. According to recent estimates by the CDC, the transmission rates of blood-borne infections such as HIV, hepatitis B virus, and hepatitis C virus through needlestick injuries are 0.3%, 6%–30%, and 1.8%, respectively. While these numbers are estimates, the actual number of occupation-related blood borne infections is unknown and could be significantly higher. These data warrant further study in identifying occupational risk factors and effective prevention methods.
Since the passage of the Needlestick Safety and Prevention Act of 2000, percutaneous injury rates decreased by 31.6% outside of the surgical setting with the widespread adoption of safety devices. However, injury rates increased by 6.5% in the surgical setting, highlighting that the surgical setting still poses significant safety risks. In addition to the increased needlestick injuries associated with surgery, medical personnel associated with these injuries are far less likely to report the incident to a hospital authority than those that occur elsewhere in the hospital. One prospective study found that as few as 4% of percutaneous injury that occur in the operating room (OR) are reported, and a recent survey of surgical residents of all subspecialties found that 51% of needlestick incidents were unreported though this was improved from 90% in older studies from the 1990s.
Exposure to blood and bodily fluids is highest within orthopedic surgery when compared to other surgical subspecialties. Given the sobering statistics showing not only an increased rate of needlestick injury but also a low rate of proper incident reporting, addressing this issue in orthopedic surgery is essential for the safety of patients and clinicians.
Although the passage of the Needlestick Safety and Prevention Act of 2000 established proper reporting techniques that have led to the development of new suture handling techniques and devices, 75% of needlestick injuries in the OR occurred as the suture was being used or passed; with surgeons and residents being most frequently injured. This risk can be minimized by utilizing methods of wound closure that do not require sutures such as staples and tissue adhesive and by adopting a hands-free suture passing technique., Although not widely utilized in the US, the hands-free suture passing technique has been shown to reduce sharp injuries by 35%–59%., Currently in the US, wound closure demands the OR surgical technologist to preload suture needles onto needle drivers that are then sequentially presented to the surgeon and passed back to the technologist after the needle has been used. With frequent passing of contaminated needles, it is unsurprising that needlestick injuries occur commonly in the OR. Operative Armourä (Sharp Fluidics®, LLC) is a novel device that enables surgeons to independently self-secure and self-dispense suture needles [Figure 1]. More specifically, it is a sterile armband that allows for suture package attachment with a needle trap device, allowing for independent and safe disposal of used suture needles.
|Figure 1: (a) Demonstration of Operative Armour self-secured suture. (b) Demonstration of the Operative Armour self-disposal container for contaminated suture|
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We hypothesized that the use of Operative Armourä (Sharp Fluidics®, LLC) as compared to the standard technique of sequentially passed needles would reduce closure time and the number of dropped and passed needles.
| Methods|| |
We enrolled three participants, all orthopedic foot and ankle fellows, at our institution for this nonrandomized controlled trial with a crossover study design. We obtained three lower-extremity cadaveric specimens for this study and utilized a standard anterior and posterior approach to the ankle joint, through a 12-cm long surgical incision, for each specimen. The surgical incisions were cross-hatched at 1-cm intervals with a surgical marking pen prior to skin incision to indicate closure points. The surgical incision was made along the marked surgical site with a 15 blade through the adipose layer superficial to the fascia. Participants were first assigned to either Group A or B and then assigned to the alternate group. In Group A, all participants utilized traditional suture passing techniques from a surgical technologist, and in Group B, participants utilized the Operative Armour device, without the assistance of a surgical technologist. The Operative Armour™ device is an arm guard device that enables surgeons to have independent access to needles and a foam insert to enable needle disposal [Figure 1]. All wound closures in both the groups were achieved with an interrupted suture technique using 2-0 vicryl pop-off suture (Ethicon, Inc.), containing five needles per pack. Each participant was instructed to close two layers of the wound, the subcuticular layer and the skin. Each participant completed three trials for Group A and B first through the anterior and then through the posterior approach. Outcome measures for wound closure included the number of needle passes, number of dropped needles, and total wound closure time. Statistical analysis of outcome measures was performed using a paired Student's t-test with P < 0.05, used for statistical significance.
| Results|| |
Outcome measures for participants in both Groups A and B including the number of needle passes, number of dropped needles, and total wound closure time are summarized in [Table 1]. In Group A, participants utilized standard suture technique, wound closure with the assistance of a surgical technologist, whereas in Group B, participants utilized the Operative Armourä device for wound closure. The average number of suture passes was significantly higher in Group A than in Group B (P < 0.05), at 52 ± 8.9 and 5.3 ± 0, respectively. The overall wound closure time was not statistically different between Group A and B (P = 0.8), at 16:35 ± 0.2 min and 16:33 ± 0.1 min, respectively. Neither of the three participants in the study dropped any needles in either group. In comparing the anterior and posterior incision, the average number of suture passes for the anterior closure was higher in Group A, 52 ± 8.9, compared to 5.3 ± 0.7 in Group B (P < 0.05) [Figure 2]. The anterior wound closure time for Group A was higher (P < 0.05) than Group B, 16:51 ± 0.2 min and 16:13 ± 0.1 min, respectively. A similar trend was observed for the posterior wound incisions. The average number of suture passes for the posterior wound incision was higher in Group A than Group B (P < 0.05), 48 ± 0.0 and 5 ± 0.0, respectively [Figure 2]. The average wound closure time for the posterior incision was higher in Group B than Group A (P ≤ 0.05), 16:53 ± 0.1 and 16:18 ± 0.2 min, respectively.
|Table 1: Wound closure time, number of dropped suture needles, and suture passes using the standard technique and the Operative Armour™ device|
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|Figure 2: Mean number of suture passes using the standard technique or the Operative ArmourTM device for the anterior and posterior approach to the ankle|
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| Discussion|| |
Although the number of surgical procedures has steadily increased in the past decade, the passage of the Needlestick Safety and Prevention Act of 2000 has done little to decrease intraoperative needlestick injuries. Coupled with low rates of incident reporting, addressing the issue of intraoperative needlestick injuries is important for patient and clinician safety. This study evaluated a novel wearable suture guard device, Operative Armour™, that aims to reduce the number of needlestick injuries associated with suture passing between the clinical team.
Surgeons utilizing Operative Armour™ compared to assistance from an experienced surgical technologist had a statistically lower number of needle handoff events, at 5.3 ± 0.7 and 52 ± 8.9, respectively, in closing the surgical wound for an anterior and posterior approach to the ankle. A multi-institutional study of occupational sharp injuries from 1993 to 2006 showed that the vast majority, 75%, of injuries from suture needles, scalpels, and disposable syringes occur during passing events. These data, in conjunction with the results of our study, suggest that novel devices, such as Operative Armour™, could significantly decrease one of the main causes of needlestick injuries in the operative setting. While our study did not show a significant difference in total wound closure time between the Operative Armour™ group and standard technique, it is possible that the use of Operative Armour™ reduces the demand on the surgical technologist for assistance and could potentially decrease OR turnaround time or enhance procedural efficiency. Further studies in more complex surgical approaches could elaborate on the efficiency of wound closure with Operative Armour™. This study also did not evaluate the effect of Operative Armour™ in settings where one surgical technologist is assisting multiple surgeons or multiple clinicians at varying levels of training or experience.
The main limitation of this study lies in the fact that this was a pilot study; however, despite the small sample size of three surgeons, we have identified statistically significant results that address a crucial need regarding safety in the OR. This simulated operative setting assumed an ideal scenario, in which one surgeon and one surgical technologist are both focused on wound closure. However, both the surgeon and surgical technologist have many more responsibilities during wound closure in the OR. Thus, the results identified from this study could be more significant in a real scenario rather than a simulation. The economic implications of the use of Operative Armour™ were not measured in this study; therefore, a larger nonrandomized control trial is warranted to further evaluate the use of Operative Armour™.
| Conclusions|| |
The use of Operative Armour™ has been shown to significantly reduce the number of suture passes when compared to the standard technique, addressing a key safety need in the operative setting to help reduced the number of needlesticks. Although wound closure time did not significantly change with the use of Operative Armour™, the reduced number of suture passes and ability for surgeons to operate without the assistance of a surgical technologist could decrease operative turnover time and enhance procedural continuity.
Needlestick injuries in the operative setting pose a significant hazard to both patients and clinicians. Given that the majority of needlestick injuries occur during needle passing events, the results from the study suggest that the Operative Armour™ device may address this crucial need.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]