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University of Groningen

New measures to prevent inguinal infections in vascular surgery

Vierhout, Bastiaan Pieter

DOI:

10.33612/diss.97720548

IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below.

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Publication date: 2019

Link to publication in University of Groningen/UMCG research database

Citation for published version (APA):

Vierhout, B. P. (2019). New measures to prevent inguinal infections in vascular surgery. Rijksuniversiteit Groningen. https://doi.org/10.33612/diss.97720548

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13

Chapter 1

General introduction and thesis outline

Surgical site infections (SSIs) are the third most common nosocomial infections, accounting for 38% of all infections after surgical interventions (1). In the year 2012, globally 312.9 million (95%CI 266.2 – 359.5 million) surgical interventions were performed (2). In the USA, a rate of SSIs of 2% to 5% of all surgeries was reported, but its’ estimated range varied widely between 1.5% and 20% (3-5). The median excess costs associated with SSI during a first hospitalization were calculated at $2,047 to $3,089 (6, 7) (equals €1,790 to €2,700) and may be generalized in the proximity of $2,500 (€2,186) with variations attributable to the procedure as well as the country of origin (3). Age and methicillin resistant Staphylococcus aureus (MRSA) status also cause large variation in costs (5). In total, with an average SSI rate of 3.5%, an additional expense of approximately $27 billion per year can be expected. And still these costs have been argued to be underestimated when related to patients with SSIs blocking in hospital beds and requiring help from related care givers, thus interfering with other productive activities (6)(Figure 1).

Surgical site infection costs:

SSI hospital impact:

SSI social impact:

SSI caregiver impact:

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A long time ago, surgery developed without anesthetics. These painful procedures were performed quickly and without sterilization. Joseph Lister was one of the last surgeons to witness such an un-anesthetized major amputation in his early medical studies in London. After the introduction of the anesthetics, he saw the infectious complications increase, due to the increasing duration of the surgical procedures. Pain during the operation was relieved and this enabled surgeons to operate longer. It took Lister three decades in the second half of the 19th century to reduce the risk of sepsis and related death after an anesthetized procedure. He eventually

developed the use of carbolic acid (8).

Only after the discovery of penicillin in the early 20st century, hospitals gradually became a safer place. One decade later, surgery evolved into its current practice, but still, local infection and generalized sepsis are feared complications of open surgery. Nowadays, we discern the value of disinfection and work with two teams in the operating room, including a sterile team and a ‘circulating’, non-sterile team. In this thesis, as well as in national guidelines, the definition of SSI is used as formulated by the Centers for Disease Control and Prevention (CDC). The definition comprises signs of redness, swelling, heat and pain or tenderness, in combination with an open wound or a positive culture (1). This definition is accepted throughout most parts of the world among which by the RIVM (Rijksinstituut voor

Volksgezondheid en Milieu = National Institute for Public Health and the Environment) in the Netherlands (9).

Different parts of the body have different SSI incidences. Although the definition remains the same for all body parts, variation exists in relation to skin

characteristics and SSI risk. Head wounds are known to cause few wound

infections, probably due to excellent vascularization. Instead, the groin is known to cause more wound problems. The groin accommodates a heavy load of microbial flora in the proximity of rectum and genitals and an abundance of lymphatic ves-sels (10-13). Comparable to the axilla, the groin is positioned at the “nipple line”, on which many sebaceous glands are known to be located (14). All of these

characteristics may explain high infection rates of up to 20% in peripheral vascular bypass surgery on the groin (15).

Apart from body localization, host characteristics play a role. The ASA classification of physical status is a strong predictor of the occurrence of SSI (16). Optimizing the general condition of the patient is advised (17). Patients with diabetes mellitus or on immunosuppressive agents have a higher rate of SSIs, and also female sex,

smoking habits and hemodialysis are identified as risk factors (12, 18).

In many efforts to reduce the number of SSIs, preoperative protocols have been adapted over the years; repeated hand washing and scrubbing of the operation site with antibacterial soaps and brushes have proven ineffective and have been abandoned in the Netherlands (19). However, a recent update of the Guideline for Prevention of SSI, from the American Medical Association, advised a shower or bath with soap on the night before the operative day (20). Cloth drapes have been replaced by disposable drapes and shaving is replaced by removal of unwanted hair with clippers, preferably performed in the operating theatre. Small series

reported an increase in SSI after shaving with a razor instead of using a clipper (21). The most effective preoperative prophylaxis is the antibiotic medication given to the patient 15 to 60 minutes before incision (11). The operating team, with scrub nurses and operating surgeon, perform one washing session at the beginning of the day, after which disinfection of hands for 1.5 minute is sufficient, provided that one does not leave the operating theatre complex. Rings and jewelry are prohibited in the operating department, and body hair should be covered with clothing or caps. During the operation, sterile draping, gloves, and laminar down flow, in combination with sterilized instruments, should prevent contamination of the wound from

outside (22). Recently, a meta-analysis concluded that laminar airflow does not protect against infections (23). True sterilization of the surgical site can never be realized (24), as bacteria are even found intradermally and may even survive intracellularly after having taken all of these measures (25). Disciplinary measures, such as the use of face masks do not lower the number of infections, but are

thought to intensify team concentration and effort (26-28). Similarly, the minimization of the number of door openings intensifies team concentration, and this does seem related to reduced SSI incidence (29). Many factors, however, may be of importance in this relation; e.g. poor preparation of the operation and complexity of the proce-dures performed (29). The development of an SSI is multifactorial and it may be concluded that various measures are still under debate.

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16 17 Towards the end of the operation, subcutaneous tissue is closed and various

skin-closure techniques are available. Non-absorbable sutures and metallic staples are often used but intra-cutaneous sutures have the advantage of solubility. The wound may be left open in contaminated procedures such as contaminated bowel surgery and drainage of abscesses (30).

After the operation, despite working in a clean environment and meticulously fol-lowing antiseptic rules, various bacterial species have the ability to initiate an SSI (8). Since the introduction of routine culture of bacteria on agar plates it has been discovered that Staphylococcus aureus (SA) causes most SSI (3, 13).

Eradication of SA would be a logical step towards further prevention of SSI, as was shown in orthopedic procedures (31). Ideally, the exact origin of the causative pathogen should be identified in advance of the operation, but studies showed it to be difficult to identify these pathogens in advance (32, 33).

Despite the above named preventive measures, the Centers for Disease Control warns for increased costs from infections due to more severe comorbidity and antimicrobial resistance (20). The resistance of the bacterial species is a troublesome development. Some countries report 50% MRSA in SA infected wounds, with increasing difficulty of treatment (26). In vascular surgery SSI

precedes a major part of infected prosthetic grafts and these infections may lead to limb amputation or even a life-threatening septicemia (10, 13, 16). Major challenges giving rise to explore novel techniques and devices invented to prevent the

occurrence of SSI, which forms the basis of this thesis.

Where do bacteria causing SSIs come from and can we completely sterilize the groin? While disinfection is the process of eliminating or reducing harmful

microorganisms from objects and surfaces, sterilization is the process of killing all microorganisms. After disinfection, remaining bacteria are probably dormant inside the skin, mostly adjacent to hair follicles, sweat glands and sebaceous glands (Figure 2), ready to recolonize the skin around the surgical wound (34).It seems logical to try to fix or glue these bacteria down to the skin in an attempt to inhibit them from activation and spreading, especially when they are concealing in the deeper layers of the skin (25). In cardiac cardiac surgery the benefit of InteguSeal®

has been reported (35), but similar results have not been shown after vascular interventions at the level of the groin. The pre-sternal skin is smooth and without folds, but the inguinal skin has folds and

multiple glands, able to contain many microorganisms.

In Chapter 2 we investigated the effects of a relatively new skin sealant device in a cohort of patients who underwent a vascular procedure through the groin.

Besides gluing bacteria down to the skin, suturing the skin in a different way could prevent infections as well. Metal staples and non-absorbable sutures have the disadvantage of creating a connection from the outer skin into the subcutaneous space. Absorbable materials do not create this connection, and have been available since the use of catgut (8). Modern

absorbable sutures consist of an absorbable

polymer. Despite the absence of connection through the skin, a disadvantage of an absorbable suture is caused by its running properties, thus sealing the skin airtight. This prevents wound fluid from evacuating through the skin. Consequently,

collections of wound fluid and lymphatic fluid may form under the incision site, with formation of hematomas or seromas, an ideal prerequisite for bacterial growth (15). Absorbable staples could solve the problem of both closure techniques; no

connection through the skin and fluid evacuation between staples. A cohort study to compare a running absorbable suture with absorbable staples was designed for patients treated with a femoropopliteal bypass, as described in Chapter 3.

Attention was paid also to methods of surgical access. Does a percutaneous technique cause less SSI compared to the open surgical access of the common femoral artery (CFA)? To answer this question we focused on a procedure routinely performed in the vascular field, i.e. the abdominal aortic aneurysm (AAA) repair.

Figure 2: Skin adnexa storing

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There are currently two ways to access such an aneurysm: the classical open surgical approach and the endovascular approach. The endovascular aneurysm repair (EVAR) has dramatically changed the vascular surgeons practice, as well asthe patient’s outcome. Although the long-term mortality does not improve, surgical complications of the open abdominal access are forestalled. Comparatively, it is anticipated that percutaneous approach of the CFA might be advantageous compared to surgical cut down, by further reduction of the invasiveness of the procedure. On the other hand, the percutaneous method might be sensed as “less controlled”, which would lead, therefore, to reduced safety (36). The invasive surgical technique may lead to more inguinal SSIs compared to the

percutaneous access of the CFA. Many studies were published reporting

advantages of this percutaneous EVAR (36), but a thorough systematic review, to bolster the body of evidence was still lacking. Therefore, we investigated available literature on patients treated for an aneurysm of the abdominal or thoracic aorta or percutaneous aortic valve implantation with either the use of an arteriotomy closure device (ACD) or surgical cut down (SCD). A comparison between ACD and SCD was made in terms of effectiveness and applicability, complications and duration of treatment in patients indicated for an endovascular procedure. A systematic review was performed and a meta-analysis of the available data is presented in Chapter 4. The two methods ACD and SCD were also investigated in a multicenter prospective randomized controlled trial carried out in the vascular units of six hospitals in the Northern part of the Netherlands. The objective was to investigate whether

percutaneous access of the CFA with an ACD would decrease the number of SSIs compared to open surgical access of the CFA in EVAR. This trial is described in Chapter 5 and its outcome in Chapter 6.

In a final effort to explain the source of a surgical site infection, microorganisms located at the incision site were analyzed. A technique for culture-free identification of microorganisms was applied to our patients of the PiERO trial and the results are described in Chapter 7. Earlier studies used these molecular methods analyzing DNA of microorganisms in tissue (37). Probably, the presence of bacteria in skin tissue may contribute to the initiation of an SSI. We used several techniques to detect the presence of skin bacteria. Nasal and groin swabs were taken for SA

culture, and skin biopsies, taken just before the surgical procedure and were investigated with conventional histology and 16S-23S next generation sequencing (NGS) of any bacterial DNA. These techniques were used in a selection of patients suffering from SSIs and in patients without SSIs.

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20 21 References

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