Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Journal of Orthopaedic Surgery 2016;24(1):67-71 Single versus double blade technique for skin incision and deep dissection in surgery for closed fracture: a prospective randomised control study Vivek Trikha,1 Pramod Saini,2 Purva Mathur,3 Abhinav Agarwal,1 Senthil V Kumar,1 Budhhadev Choudhary1 Department of Orthopaedics, JPNATC, AIIMS, New Delhi, India Department of Spine Surgery, PD Hinduja Hospital & MRC, Mahim, Mumbai, India 3 Department of Microbiology, JPNATC, AIIMS, New Delhi, India 1 2 ABSTRACT Purpose. To compare blade cultures in surgery for closed fracture using a single or double blade technique to determine whether the current practice of double blade technique is justified. Methods. 155 men and 29 women aged 20 to 60 (mean, 35) years who underwent surgery for closed fracture with healthy skin at the incision site were included. Patients were block randomised to the single (n=92) or double (n=92) blade technique. Blades were sent for bacteriological analysis. Outcome measures were early surgical site infection (SSI) within 30 days and cultures from the blades. Results. The 2 groups were comparable in baseline characteristics. In the single blade group, 6 surgical blades and 2 control blades showed positive cultures; 4 patients developed SSI, but only one had a positive culture from the surgical blade (with different organism isolated from the wound culture). In the double blade group, 6 skin blades, 7 deep blades, and 0 control blade showed positive culture; only 2 patients had the same bacteria grown from both skin and deep blade. Five patients developed SSI, but only one patient had a positive culture from the deep blade (with different organism isolated from the wound culture). The difference in incidence of culture-positive blade or SSI between the 2 groups was not significant. The relative risk of SSI in the single blade group was 0.8. Positive blade culture was not associated with SSI in the single or double blade group. Conclusion. The practice of changing blade following skin incision has no effect on reducing early SSI in surgery for closed fracture in healthy patients with healthy skin. Key words: orthopedic procedures; surgical wound infection INTRODUCTION It is a traditional practice to change a surgical blade after skin incision and use a new blade for deeper dissection to prevent surgical site infection (SSI).1 SSI Address correspondence and reprint requests to: Pramod Saini, Department of Spine Surgery, PD Hinduja Hospital & MRC, Mahim, Mumbai, India. Email: [email protected] 68 Journal of Orthopaedic Surgery V Trikha et al. is defined as infection at or near the surgical incision occurring within 30 days (extended to 1 year in the presence of an implant) of surgery, and is the most common category of nosocomial infection among surgical patients.2–5 Most early SSIs are caused by skin commensals.6 Some studies have suggested abandoning this ‘double blade’ technique,7–13 based on blade cultures and few incidence of infection. Others recommend continuing the practice because of blade contamination.14–16 This study compared blade cultures in surgery for closed fractures using the single or double blade technique to determine whether the current practice of double blade technique is justified. MATERIALS AND METHODS This prospective randomised controlled blinded study was approved by the institutional ethical board and registered with the Clinical Trials Registry of India. Informed consent was obtained from each patient. According to the Consolidated Standards of Reporting Trials guidelines,17 155 men and 29 women aged 20 to 60 (mean, 35) years who underwent surgery for closed fracture with healthy skin at the incision site between January and July 2013 were included. Patients with open fracture, skin disease, compromised skin and soft tissue around the incision site, reoperation, chronic immunosuppressive conditions, diabetes or other systemic diseases, or who were unable to give informed consent or refused to participate were excluded. Patients were block randomised to the single (n=92) or double (n=92) blade technique. Surgery was carried out in an operating theatre with laminar airflow ventilation. First-generation cephalosporin was given half an hour before skin incision; a repeat dose was given if the operating time exceeded 2 half-lives of the drug. Antibiotics were discontinued 24 hours after surgery. Skin was prepared with 4% chlorhexidine gluconate and then 10% povidone iodine. An antibacterial-impregnated barrier (Ioban, 3M, USA) was used. Blades were transferred to sterile containers by the scrub nurse immediately after use. To control for false-positive results secondary to environmental contamination, an unused blade kept on the instrument table was also sent for bacteriological analysis. The blades were pressed onto culture plates, which was then transferred to Robertson cooked meat broth for enrichment. Post incubation in the enrichment media both aerobic and anaerobic subculture was taken. Blood and MacConkey agar was used for aerobic bacteria. Anaerobic blood agar plates were supplemented with brain heart infusion, vitamin K, and haemin. Postoperatively, surgical wounds were examined after 48 hours and then daily until discharge and at days 14 and 30. Wounds were considered infected if 2 of the following were present: (1) seropurulent discharge, (2) positive culture of exudates, and (3) local signs and symptoms of infection such as redness, swelling, increased local temperature.2–4 All patients were instructed to report to the hospital for any symptoms of infection. Any discharge from the wounds was swabbed and sent for bacteriological analysis. Outcome measures were early SSI within 30 days and cultures of the blades. The 2 groups were compared using the Mann-Whitney U test for continuous variables and the Chi-squared test or Fisher exact test for categorical variables. The upper boundary of the 95% confidence interval (CI) for difference in the incidence of SSI between 2 groups was not >1%. An intent-to-treat-analysis was used. The latest follow-up data were used for any missing data. RESULTS Of the 184 patients, one patient in the single blade group died in the early postoperative period, and 2 patients in the single blade group and one in the double blade group were lost to follow-up. The remaining 89 patients in the single blade group and 91 patients in the double blade group completed the entire follow-up. The 2 groups were comparable in terms of baseline characteristics (Table 1). In the single blade group, 6 surgical blades and 2 control blades showed positive cultures; 4 patients developed SSI, but only one had a positive culture from the surgical blade (with different organism isolated from the wound culture). In the double blade group, 6 skin blades, 7 deep blades, and 0 control blade showed positive cultures; only 2 patients had the same bacteria grown from both skin and deep blades. Five patients developed SSI, but only one patient had a positive culture from the deep blade (with different organism isolated from the wound culture). The difference in incidence of culture-positive blade between the 2 groups was not significant (p=0.220). Respectively in the single and double blade groups, the incidence of SSI was 4.35% (95% CI=0.18– Vol. 24 No. 1, April 2016 Single versus double blade technique in surgery for closed fractures 69 Table 1 Baseline characteristics of patients in the single and double blade groups* Single blade group (n=92) Age (years) No. of males: females Delay in surgery (days) Length of hospital stay (days) American Society of Anesthesiologists Grade 1 Grade 2 Duration of surgery (minutes) Bone involved Femur Tibia Foot Patella Humerus Radius & ulna Hand Pelvis & acetabulum Spine Clavicle Type of implant used Intramedullary nail Plate Screw Prosthesis Double blade group (n=92) 35.1 (20–60) 78:14 2.9 (1-10) 9.5 (2-21) 34.1 (20–60) 77:15 3.2 (1-9) 9.2 (3-21) 74 18 110.4 (35–200) 70 22 106.7 (45–200) 47 17 1 2 8 1 1 12 2 1 36 15 1 0 9 11 0 15 4 1 24 54 11 3 63 22 6 1 p Value 0.530 0.728 0.132 0.754 0.409 0.331 0.112 0.341 * Data are presented as mean (range) or no. of patients Table 2 Patients with positive culture in any of the surgical or control blade or surgical site in the single blade group Patient no. 3 17 26 28 29 38 46 50 74 79 Surgical blade Control blade Diptheroids Sterile S epidermidis Sterile S epidermidis S epidermidis Sterile Acinetobacter baumenii Sterile S aureus Sterile Sterile Sterile Sterile Sterile Sterile Pseudomonas S hominis Sterile Sterile Surgical site infection Escherichia coli Klebsiella Enterococcus faecalis E coli Table 3 Patients with positive culture in any of the skin, deep, or control blade or surgucial site in the double blade group Patient no. 2 11 15 17 18 32 35 39 42 51 55 59 86 90 91 Skin blade Deep blade Control blade Sterile Micrococcus Sterile Diptheroids Sterile Sterile Sterile Sterile Sterile S epidermidis S haemolyticus S epidermidis Sterile S hominis Sterile S xylosus Sterile Sterile Sterile S aureus S epidermidis S hominis Sterile Sterile S epidermidis Sterile Sterile S xylosus S hominis Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Sterile Surgical site infection Proteus Klebsiella Acinetobacter baumenii Enterococcus faecalis Enterococcus faecalis 70 Journal of Orthopaedic Surgery V Trikha et al. 8.5%) and 5.43% (95% CI=0.8–10.06%) based on intention-to-treat analysis, and was 4.49% (95% CI=0.19–8.79%) and 5.49% (95% CI=0.81–10.17%) based on per protocol analysis, with the difference in incidence being -1.09% (95% CI= -0.0899 to 0.0681); the negative value indicated in favour of the single blade group. The difference in incidence of SSI between the 2 groups was not significant (p=0.500 in intention-totreat analysis, p=0.514 in per protocol analysis, onesided test). The relative risk of SSI in the single blade group was 0.8 (95% CI=0.221–2.884) in the intentionto-treat analysis and 0.81 (95% CI=0.226–2.947) in the per protocol analysis. Positive blade culture was not associated with SSI in the single blade group (p=0.126) or the double blade group (skin blade: p=0.577, deep blade: p=0.283). DISCUSSION The practice of changing surgical blade after skin incision to prevent SSI can be traced back to the pre-antibiotic era in which microorganisms were isolated from sweat and surgically prepared skin.18,19 Changing blades became a routine practice following introduction of the ‘no touch technique’.20 Skin harbours microorganisms, mostly bacteria, which can be broadly divided into resident flora that permanently reside on skin in superficial layers of the epidermis and the appendages, and transient flora that is transferred from the environment to the skin for a short period.21 These microbes are usually non-pathogenic and act as commensals, but can be pathogenic in patients with local or systemic immunity problems. Preoperative preparation of skin with antiseptics reduces the number of microorganisms on skin but cannot completely eradicate them, especially the resident flora.22 Hypothetically, whenever the skin is incised, microorganisms that colonise the deeper layers of skin can contaminate the exposed tissues and lead to SSI. The most common blade culture isolated is coagulase negative staphylococcus, which is a skin commensal.14,15 Some studies reported higher bacterial isolation rate from skin than deep blades; this theoretically can lead to an increase in SSI if the blade is not changed, but the actual infection rate was not measured.14,15 In our study, using a separate blade for skin and deep incision did not result in reduced SSI. The deep blade could be equally contaminated with skin flora, and patients with positive blade cultures did not necessarily develop SSI. Moreover, positive culture from control blades indicated non-operative contamination. Nonetheless, the cost of treating SSI is much higher than that of a new blade.14 If the double blade technique is logically sound, why suture needles that pass through the skin many times have never been reported to increase the risk of SSI.23–25 There were a few limitations to this study. A power analysis should have been performed. A larger sample may have been needed to show a significant difference between groups, because the incidence of SSI is low after clean operations for healthy patients with closed fracture and healthy skin. Nonetheless, there is no study with strong methodological basis that can determine the effect of changing surgical blade on the incidence of SSI in this population. In addition, although the surgeon was blinded as to whether the blade was the same or changed by the scrub nurse, he may have guessed by the presence or absence of blood on the blade. In addition, the follow-up was short and potential cases of SSI could have been missed, because patients with an implant remain susceptible for SSI up to a year.2 Nonetheless, only early SSI that occurs within 30 days is related to skin commensals. The findings of this study can only be generalised to healthy patients with closed fracture with clean and healthy skin, rather than those with open fracture, systemic disease, or unhealthy skin. CONCLUSION The practice of changing blade following skin incision has no effect on reducing early SSI in surgery for closed fracture in healthy patients with healthy skin. DISCLOSURE No conflicts of interest were declared by the authors. REFERENCES 1. Tejwani NC, Immerman I. Myths, and legends in orthopaedic practice: are we all guilty? Clin Orthop Relat Res 2008;466:2861–72. 2. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a Vol. 24 No. 1, April 2016 Single versus double blade technique in surgery for closed fractures 71 modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol 1992;13:606–8. 3. Peel AL. Definition of infection. In: Taylor EW, editor. Infection in surgical practice. Oxford: Oxford University Press; 1992:82–7. 4. Ward HR, Jennings OG, Potgieter P, Lombard CJ. Do plastic adhesive drapes prevent post caesarean wound infection? J Hosp Infect 2001;47:230–4. 5. Watanabe A, Kohnoe S, Shimabukuro R, Yamanaka T, Iso Y, Baba H, et al. Risk factors associated with surgical site infection in upper and lower gastrointestinal surgery. Surg Today 2008;38:404–12. 6. Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med 2004;351:1645–54. 7. Jacobs HB. Skin knife-deep knife: the ritual and practice of skin incisions. Ann Surg 1974;179:102–4. 8. Ritter MA, French ML, Eitzen HE. Bacterial contamination of the surgical knife. Clin Orthop Relat Res 1975;108:158–60. 9. Fairclough JA, Mackie IG, Mintowt-Czyz W, Phillips GE. The contaminated skin-knife. A surgical myth. J Bone Joint Surg Br 1983;65:210. 10. Hasselgren PO, Hagberg E, Malmer H, Saljo A, Seeman T. One instead of two knives for surgical incision. Does it increase the risk of postoperative wound infection? Arch Surg 1984;119:917–20. 11. Grabe N, Falstie-Jensen S, Fredberg U, Schröder H, Sörensen I. The contaminated skin-knife: fact or fiction. J Hosp Infect 1985;6:252–6. 12. Hill R, Blair S, Neely J, Ramanathan M. Changing knives a wasteful and unnecessary ritual. Ann R Coll Surg Engl 1985;67:149–51. 13. Ramon R, Garcia S, Combalia A, Puig de la Bellacasa J, Segur JM. Bacteriological study of surgical knives: is the use of two blades necessary? Arch Orthop Trauma Surg 1994;113:157–8. 14. Schindler OS, Spencer RF, Smith MD. Should we use a separate knife for the skin? J Bone Joint Surg Br 2006;88:382–5. 15. Davis N, Curry A, Gambhir AK, Panigrahi H, Walker CR, Wilkins EG, et al. Intraoperative bacterial contamination in operations for joint replacement. J Bone Joint Surg Br 1999;81:886–9. 16. Matar WY, Jafari SM, Restrepo C, Austin M, Purtill JJ, Parvizi J. Preventing infection in total joint arthroplasty. J Bone Joint Surg Am 2010;92(Suppl 2):36–46. 17. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152:726–32. 18. Welch WH. Conditions underlying the infections of wounds. Am J Med Sci 1891;102:438–41. 19. Welch WH. General bacteriology of surgical infections. In: Dennis FS, editor. System of surgery. Philadelphia: Lea Bros; 1895:25. 20. Fu LK. History of orthopaedics. Great names in the history of orthopaedics XIII: William Arbuthnot Lane. Hong Kong J Orthop Surg 2010;14:52–62. 21. Lilly HA, Lowbury EJ. Transient skin flora: their removal by cleansing or disinfection in relation to their mode of deposition. J Clin Pathol 1978;31:919–22. 22. Selwyn S. Skin preparation, the surgical ‘scrub’ and related rituals. In: Karran S, editor. Controversies in surgical sepsis. New York: Praeger; 1980:23–32. 23. Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, et al. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol 2013;121:33–8. 24. Shuster M. Comparing skin staples to sutures. Can Fam Physician 1989;35:505–9. 25. Smith TO, Sexton D, Mann C, Donell S. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. BMJ 2010;340:c1199.