Impose?:Mise en page 1 - Digestive Health

New non-pharmaceutical 

ways to reduce Surgical 

Site Infections 

Clinical Testimonials on 

Pathogen Control and 

Temperature Management : 

■ Privat-Dozent Pascal M. Dohmen PhD 

Charite Hospital, Medical University Berlin, Germany 

■ Professor Samuel E. Wilson 

University of California, Irvine, USA 

■ Dr Dheeraj Mehta 

University Hospital of Wales, Cardiff, UK 

■ Dr Peer Hofmann 

Krankenhaus Nordwest, Frankfurt, Germany 

■ Dr Benchetrit 

Clinique Jeanne d’Arc, Lyon, France

KIMBERLY-CLARK* 

Testimonial


Testimonial 

Clinician testimonial 

Based on an interview with 

Professor Samuel E Wilson, from the University of 

California, Irvine, USA 

Interview conducted by Neil McKendrick PhD, 

as part of the Kimberly-Clark symposium 

New non-pharmaceutical ways to reduce surgical 

site infections. 

Locking down pathogens to lock out contamination 

Professor Samuel E Wilson, from the University of California, Irvine, USA, is the 

lead investigator of the first clinical trial with InteguSeal in surgical patients. 

“Our clinical trial design aimed to focus on a common operation, where 

infection is not expected but would compromise the effectiveness of the 

procedure should it occur. We selected inguinal hernia repair for the trial for 

several reasons. It is a very common procedure and one does not expect 

postoperative infection because it is a clean surgical wound. But if an 

infection does occur, it undermines the whole purpose of the operation: if a 

prosthesis has been implanted, it will have to be removed and secondary 

repair of the hernia will be necessary. Furthermore, it can be difficult to apply 

standard adhesive drapes in the area of the inguinal skin fold. 

I should point out that our goal in the trial was not to compare infection rates 

between InteguSeal and a control, because the numbers would be low – 

perhaps about one in a hundred procedures. Our aim was to show whether 

InteguSeal reduced the recovery of bacteria from the wound: did InteguSeal 

secure the skin flora so that they did not enter the operative field? 

Our trial involved 177 patients at five sites in the US. Each patient underwent 

standard skin preparation with Betadine scrub, after which half were 

randomized to receive InteguSeal . We recognized that if we used wound 

infection as our endpoint we would require several thousand patients to 

show a significant difference between the groups. However, we believed 

that if we could show a significant reduction in wound contamination with 

InteguSeal , surgeons could accept this as a great advantage for ultimately 

preventing wound infection. To do this we used a specially developed 

procedure to obtain cultures from the subcutaneous tissue immediately after 

making the incision, and immediately before closing the fascia and skin: the 

average duration of the procedure was about 1 hour.”


Testimonial 

The results of this study showed that wound contamination was present in 

53.0% of patients in whom InteguSeal was used, compared with 68.7% in the 

control group, that is a 16% reduction (P=0.04). This benefit of InteguSeal was 

seen at all sites, and was independent of the use of prophylactic antibiotics 

or removal of body hair by clipping. 

“We have since used InteguSeal in our routine clinical practice. The nurse 

applies InteguSeal as part of the standard skin preparation, a practice which 

has worked very well. InteguSeal is very easy to put on the skin, and it 

adheres very tightly. I think InteguSeal has great application, also for those 

areas where it is difficult to apply antiseptic-impregnated drapes. It is particularly 

useful in areas where there are skin folds, and for most standard operative 

procedures. The only thing to note is that the skin has to be dry before 

application. 

One unexpected question that came up during our study was: how does 

InteguSeal come off the skin? It exfoliates naturally from the patient’s skin : 

we found that in most patients InteguSeal was quickly removed once they 

started taking showers or baths (on average, about 72 hours after the procedure). 

After 1 week, there was very little evidence of residual InteguSeal remaining 

on the skin. 

Postoperative infections are expensive complications because the patient’s 

hospitalization is prolonged and extensive treatment may be needed. The 

prevention of one wound infection will go a long way towards countering any 

costs incurred in using InteguSeal . In general, hospital administrators want 

to keep their costs down: they want surgeons to get their patients home as 

soon as possible, and avoiding complications is one way to do that. 

Looking into the future, I think that InteguSeal is likely to become a routine 

part of operative procedures. Non-antimicrobial methods of preventing 

infection are likely to become increasingly important; although antibiotics 

are irreplaceable for contaminated procedures such as gastrointestinal 

surgery their role in clean procedures remains somewhat controversial. 

I believe that there will be a renewed emphasis on operating room discipline, 

with every effort being made to prevent wound contamination with skin 

bacteria. This is where I believe InteguSeal has the best role.”


Testimonial


Testimonial 


Based on an interview by Pascal M. Dohmen MD PhD 

(Charité Hospital, Medical University Berlin, Berlin, Germany) 


22 June 2007, at the SAS Radisson Hotel in Reykjavík, Iceland 


New non-pharmaceutical ways to reduce surgical site infections. 

InteguSeal ® : a promising development for surgical site infection 

prophylaxis 

As a cardiac surgeon in the Department of Cardiovascular Surgery at the 

Charité University Hospital in Berlin, I perform a wide range of cardiac surgery 

procedures in adult patients, including cardiac bypass surgery, aortic surgery, 

valve surgery, and Ross procedures (aortic valve replacement with the autologous 

pulmonary valve). With four of our six surgeons available at any one time, plus the 

head of the department, Professor Konertz, and nine resident trainee staff, we carry 

out approximately 1500 operations every year. In addition to this, as a large 

cardiovascular surgery university department, we also have substantial teaching 

and research commitments. 

I also lead the research department of the Tissue Engineering Section and 

our main area of research interest is the development of new heart valves 

using tissue engineering 1–3 . Patients undergoing cardiothoracic surgery are 

at substantial risk of developing SSI, 4 so as a cardiac surgeon, I am also 

interested in the prevention of SSI. 

SSI can be devastating in cardiac surgery patients 

We already have a quality management programme in our department and 

soon all hospitals in Germany will be required to publish their results for 

surgical outcomes from the previous year. The effect of this will be to generate 

competition between hospitals because patients will compare results across 

centres before choosing the one at which they prefer to be treated. So high 

quality outcomes, while clearly important for patients, are also important for 

clinical centres. A major issue in terms of treatment outcomes is the incidence 

of SSIs, which remains one of the main complications of cardiac surgery. 

The prevalence of SSIs among patients undergoing cardiothoracic surgery 

has been reported to range from 1.3% to 12.3%, while sternal SSI may occur 

in up to 20% of patients 5,6 . SSIs are associated with increased morbidity in 

cardiac surgery patients; mediastinitis, for example, has devastating consequences. 

In addition, sternal wound complications often have a late onset and are 

detected after patients are discharged from the hospital. Retrospective data 

estimate that SSIs contribute 1.47-19.1 billion Euros to the economic costs of 

surgical procedures in Europe 7 .


Testimonial 

While the quality of outcomes is excellent across hospitals in Germany, with 

generally low rates of adverse surgical outcomes, outcome rates are a key 

factor considered by patients when selecting a hospital. More high-risk 

patients are normally treated at the university or other public hospitals, and 

the more high-risk patients treated at a centre, the higher the rate of adverse 

treatment outcomes for that centre is likely to be. This also emphasizes the 

importance of reliable detection and accurate reporting of SSI rates. 

An ageing population: more elderly patients 

In Germany, as in many European countries, populations are becoming older. 

Increasing numbers of very elderly patients are being referred for valve and 

other cardiac surgery. Although valve surgery achieves good long-term 

survival and an improved function in elderly patients, many have a wide 

variety of chronic, debilitating, or immunocompromising concomitant, often 

subclinical, diseases that contribute to increased risk of SSI 8 and postoperative 

morbidity and mortality. 

Prevention is better than treatment 

Effective antibiotics are an essential weapon with which to fight SSI. But we 

know from our microbiologist colleagues that there is increasing antibacterial 

resistance, particularly among common nosocomial pathogens. Both 

staphylococci and enterococci have developed alarming rates of resistance 

to multiple antibiotics 9 , but the resistance to antibiotics of other Gram-positive 

organisms, including micrococci, diphtheroids and Propionibacterium acnes, 

and Gram-negative bacilli is also a major concern 10 . What we need are better 

ways of preventing SSI without medication and without antibiotics, and this is 

where pharmaceutical companies and medical device companies can help. 

Clinical experience is growing 

After InteguSeal ® was introduced in our hospital approximately 18 months 

ago, we conducted a pilot study in 40 surgical patients. Of these patients, 

there was one patient with a major risk factor who developed a SSI. With 

treatment, this patient recovered very quickly from the infection and made 

good subsequent progress. There were several other patients with major 

risk factors in the study who did not develop SSI, which confirmed my belief 

that this was a useful adjunct to current practice for minimising SSI. Since 

the pilot study, I have used it on all my patients, while others in our surgical 

team use it for bypass surgery and particularly for procedures such as a bilateral 

internal mammary artery grafting which increases the risk of sternal SSI, 

especially with diabetic patients. After more than 100 cases in which InteguSeal ® 

has been used, there has been only one case of SSI (the patient in the pilot study). 

I use InteguSeal ® only on the area for thoracic incision and not on the legs 

or on the arm because, although we also harvest major vessels from the 

limbs, the rate of postoperative infections at these sites is very low in our


Testimonial 

institution. Before applying InteguSeal ® , I think it is important to first disinfect 

the patient with iodine solution and let the preparative solution dry, which 

takes about three to five minutes. We then leave InteguSeal ® to dry for the 

recommended time before we put the drapes in place. 

Using the InteguSeal ® 100, we treat across the chest from nipple to nipple 

and then as far down the abdomen as possible. I also apply InteguSeal ® 

around the area where the drainage tubes are positioned. InteguSeal ® is 

easy to use, although occasionally it is difficult to see when dried on skin. 

This is likely to change as versions of the product are developed with the 

addition of colouring to allow it to be seen more easily after application. 

Efficacy not cost is the priority for SSI reduction 

As a doctor, it is the health and well-being of my patients that are my priorities 

and it is far more important to me to reduce the risks of co-morbidity, particularly 

for higher risk patients, than to achieve the reductions in the cost of healthcare. 

Being realistic, however, I accept that financial considerations and budgets 

are part of managing healthcare today and most medical departments’ budgets 

are limited. In many cases the decision to acquire new technology needs to 

be based on evidence of cost and benefit. This is not least because there are 

other new healthcare products – drugs, medical devices and so on – that are 

also likely to benefit patients that have to be considered. However, InteguSeal ® 

has the advantage of being probably the first non-pharmacological product that 

can be used in all surgical patients to reduce the risk of SSI. In the context 

of this clinical problem, if we can avoid, for example, one patient developing 

a deep sternal infection, we would save approximately 40,000 Euros. So, if a 

calculation is required, the acquisition costs of InteguSeal ® can reasonably be 

offset against part of the potentially high financial cost of the SSI disease 

burden. In my view, if we save one patient from the consequences of SSI, it 

would be already have been a worthwhile investment. 

More clinical data will support a sound concept 

My centre is participating in the clinical study initiated by Kimberly-Clark 

investigating the effect of InteguSeal ® on the recovery of bacteria from 

surgical wounds. I hope to extend this work and conduct a controlled study 

in high risk patients, who are more likely to develop SSI, who would be 

randomised to surgery with and without InteguSeal ® . Detection of a reduction 

of SSI would clearly provide further support for the use of this product, but at 

this point in time, should surgeons start to use InteguSeal ® , or should they 

wait for the data to emerge? I know that some of my surgeon colleagues in 

Germany, The Netherlands and Belgium, who are quite conservative, are not 

using InteguSeal ® yet because they are waiting for outcome data to be 

reported on which to base their decision. Obviously, each has to make their 

own judgement, but I would say use it. The scientific concept underpinning 

Integuseal is attractive, while the in vitro studies and early clinical data are 

encouraging and provide clear support for the concept. We now need to build


Testimonial 

the clinical data and clinical evidence that will convince the wider surgical 

population. 

InteguSeal ® may have broader clinical utility 

The problem with studies conducted in low risk patients is that it often takes 

too many patients and/or too long follow-up to see any difference between 

treatment groups. I think we should test Integuseal in higher risk patients 

where we could see a bigger or earlier treatment effect. This could be 

cardiac surgery patients or it could, for example, be patients undergoing liver 

transplantation; another patient group at high risk of SSI 11 . 

In addition to surgery, I think other possible clinical applications of InteguSeal ® 

should be considered. Drugs for anaesthesia or analgesia, for example, are often 

infused via i.v. catheters for extended periods. Similarly, critically ill patients who 

require prolonged treatment in the ICU often have central venous lines in place 

for several days. InteguSeal ® could be applied around the catheterisation site 

with reapplication every 5–7 days to could reduce the high risk of SSI in these 

patients. Similarly, patients in cardiogenic shock often receive haemodynamic support 

by intra aortic balloon counterpulsation in which an inflatable balloon is inserted 

through a catheter in the femoral artery into the descending thoracic aorta. In 

these and other patients where the need for catheters provides skin flora and other 

pathogens an opportunity for direct access to the blood, application of InteguSeal ® 

around the catheterisation site might reduce the high risk of SSI. 

References 

1. Dohmen PM, da Costa F, Yoshi S et al. Histological evaluation of tissue-engineered heart valves implanted in the 

juvenile sheep model: is there a need for in-vitro seeding? J Heart Valve Dis 2006; 15: 823–9. 

2. Erdbrugger W, Konertz W, Dohmen PM et al. Decellularized xenogenic heart valves reveal remodeling and growth 

potential in vivo. Tissue Eng 2006; 12: 2059–68. 

3. Gabbieri D, Dohmen PM, Linneweber J, Lembcke A, Braun JP, Konertz W. Ross procedure with a tissue-engineered 

heart valve in complex congenital aortic valve disease. J Thorac Cardiovasc Surg 2007; 133: 1088–9. 

4. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR, the Hospital Infection Control Practices Advisory Committee. 

Guideline for prevention of surgical site infection, 1999. Infect Control Hosp Epidemiol 1999; 20: 250-78. 

5. Segers P, de Jong AP, Kloek JJ, Spanjaard L, de Mol BA. Risk control of surgical site infection after cardiothoracic 

surgery. J Hosp Infect 2006; 62: 437–45 

6. Segers P, de Jong AP, Spanjaard L, Ubbink DT, de Mol BA. Randomized clinical trial comparing two options for postoperative 

incisional care to prevent poststernotomy surgical site infections. Wound Repair Regen 2007; 15: 192–6 

7. Leaper DJ, van Goor H, Reilly J et al. Surgical site infection - a European perspective of incidence and economic 

burden. Int Wound J 2004; 1: 247–73. 

8. Kaye KS, Sloane R, Sexton DJ, Schmader KA. Risk factors for surgical site infections in older people. J Am 

Geriatr Soc 2006; 54: 391-6. 

9. Wilson MA. Skin and soft-tissue infections: impact of resistant gram-positive bacteria. Am J Surg 2003; 186: 35S- 

41S, 42S-43S, 61S-64S. 

10. Dohmen PM. Influence of skin flora and preventive measures on surgical site infection during cardiac surgery. 

Surg Infect (Larchmt) 2006; 7 (Suppl 1): S13–7. 

11. Kibbler CC. Infections in liver transplantation: risk factors and strategies for prevention. J Hosp Infect 1995 30 

(Suppl): 209–17


Testimonial


Testimonial 

Interview with Dr Benchetrit 

GENERALE DE SANTE 

Reducing the risks of SSI with InteguSeal 

We met with Dr Benchetrit at the Clinique Jeanne d’Arc in Lyon. He uses 

the Kimberly-Clark microbial sealant InteguSeal. This product seals and 

immobilizes skin flora, the principal source of surgical site infections (SSI). 

Dr Benchetrit is a surgeon who has been working in digestive and visceral 

surgery for 15 years. He specialises in laparoscopic surgery and obesity. 

He performs procedures on the abdominal wall, for obesity, and on the 

biliary and colorectal tracts in around 1000 patients a year. 

SSI 

Have you already had cases of SSI? 

Of course, and particularly in our specialty because we are handling viscera that 

are often infected. We have had infections despite all the methods and resources 

implemented to combat them. In laparoscopic abdominal wall surgery, we have almost 

0% of SSI, but as soon as we open up the patient, there are 3% to 5% of infections. 

What are the consequences? 

We can manage the human consequences, but extended lengths of stay can 

pose problems in healthcare establishments. It takes much longer for the patient 

to return to normal activities, and sick leave needs to be extended, which 

represents a major cost to society. 

Medicine is becoming increasingly involved in litigation, and hospital-acquired 

infections attract considerable media attention. They are the leading cause of 

complaints by patients. 

What are the major challenges and problems linked to preventing SSI? 

The challenge is 0% of SSI, but I think this is impossible. A whole range of 

preventive measures are possible, and we apply them routinely. 

In your opinion, is skin flora one of the major sources of SSI? 

Yes. It is the principal cause, apart from septic surgery, notably of the digestive 

tract, because as soon as it is manipulated, it is not the skin that contaminates, 

but these organs. For all other types of procedures, it is the skin. 

The choice of InteguSeal 

You use InteguSeal as a tool to reduce the risk of SSI. Can you explain the 

reasons for this choice? 

InteguSeal acts silently and invisibly, which is ideal for a surgeon. In addition 

to this product's efficacy, there is much to be said for its practical value. 

Do you know how much an SSI costs? 

I have no idea, but it must be a lot. In terms of global costs, account must be 

taken of the extended length of stay and social costs, which are rising all the 

time. As for direct costs, we must include the use of antibiotics.


Testimonial 

"The cost of an SSI treated with antibiotics for 15 days is higher than the application of 

30 InteguSeal" 

By using InteguSeal you ensure additional security for your patients. Is this 

a decisive factor in your choice of InteguSeal? 

Of course. We have a product that exerts a preventive action. It would be 

unethical not to use it. 

Are there other reasons that have led you to make this choice? 

"The attraction of efficacy and ease of handling, without changing our protocols" 

It is very important not to need to change anything, as our teams are well organized. 

We apply the following standard protocol: 

- Asepsis, involving skin cleansing with antiseptic soap. 

- Drying 

- First layer of asepsis 

- Second layer of asepsis 

- Application of InteguSeal 

- Drying 

"InteguSeal in practice" 

You use the Kimberly-Clark microbial sealant InteguSeal, which seals and 

immobilizes skin flora. It is applied after the patient's skin has been prepared 

and before any incision is made. 

How long have you been using InteguSeal? How many times have you used 

it, and during which types of procedure in particular? 

We were amongst the first to introduce this product. I have been using it for 

9 months, once or twice a week. I tend to use it during open procedures or 

emergency operations. 

Is the application of InteguSeal sealant simple/easy? Have you experienced 

any problems? 

Yes, there is nothing more simple. We have not had any problems. Initially, I 

applied it myself, but now it is my surgical assistant who does so. The use of 

InteguSeal has become standard in our surgical practice. 

"Innovation and prevention" 

Do you know of any products that are comparable to InteguSeal? 

Comparable in terms of efficacy and ease of use, no, I know of no other. 

Would you recommend InteguSeal to your colleagues? 

Yes, of course. 

Do you warn your patients that you are going to use InteguSeal during their surgery? 

No, for them it changes nothing. They cannot think that we will not take every 

precaution to prevent problems. 

Do you have any other comments you would like to make? 

"I am very pleased with the product. In view of its proven efficacy, we use it routinely in 

specific areas" 

We would like to thank Dr Benchetrit to have given us the time for this interview.


Testimonial


Testimonial 


Based on an interview by 

Dr Dheeraj Mehta (University Hospital of Wales, Cardiff, UK) 


21–22 June 2007, at the SAS Radisson Hotel in Reykjavík, Iceland 

as part of the Kimberly-Clark Symposium 

New non-pharmaceutical ways to reduce surgical site infections 

Better perioperative temperature control would improve outcomes 

in most surgical procedures 

As a consultant cardiothoracic surgeon at the University Hospital of Wales 

in Cardiff, I carry out a wide range of cardiac procedures, including cardiac 

valve replacement and repair procedures, aortic surgery and coronary artery 

bypass (CAB) surgery. My surgical interest is coronary revascularisation and 

I have a particular interest in developing the technique of off-pump CAB 

(OPCAB) surgery in our surgical unit. OPCAB surgery offers advantages on 

several clinical outcomes and healthcare resource utilization compared with 

conventional on-pump CAB surgery. 1–4 

Improving outcomes in cardiac surgery 

In CAB surgery, outcomes for patients have progressively improved in 

recent years, with refinements in surgical technique together with evolving 

perioperative procedures contributing to lower postoperative morbidity and 

mortality. Yet, we have been operating on growing numbers of high risk 

patients, who are representative of an ageing population that includes greater 

proportions of patients with comorbid conditions such as obesity and 

diabetes. 5 The increased prevalence of co-morbid disease among the overall 

surgical patient population does, however, present challenges if we are to 

improve outcomes further. 

Historically, cardiac surgeons have measured performance and outcomes 

on the basis of surgical mortality, such as in-hospital or 30-day mortality per 

type of procedure. In low-risk patients, outcomes of CAB surgery are excellent, 

so measurement of mortality rates, which are generally less than 2%, 6 is neither 

a specific or sensitive indicator of surgical performance. More recently, 

morbidity, rather than mortality, has emerged as a marker of performance 

and quality, with measures such as patient transit through operative 

procedures and the incidence of complications in the postoperative period that 

impact on the duration of hospital stay or on the patient’s quality of life.


Testimonial 

Several factors have contributed to this change in surgical performance 

assessment. For example, patients’ attitudes and their relationship with 

physicians have changed in recent years. Patients are now more questioning 

of the healthcare process, and their awareness and expectations are 

higher; they want the best possible outcome from any intervention that is 

undertaken and they are both aware and concerned about what potential 

complications might occur and what the risk of those potential complications 

could be. In addition, healthcare trusts in the UK are coming under increasing 

pressures to constrain their budgets and improve productivity by meeting 

healthcare targets using limited or reducing budgets. In consequence, 

healthcare managers are very keen to ensure optimal patient throughput 

with minimal morbidity. So, it is important for surgeons and other medical 

staff to identify where and how improvements in perioperative management 

can be made. 

Collaboration between the medical profession and pharmaceutical and medical 

device manufacturers in the development of new drugs and technologies, 

which is an essential part of this process of improvement, has increased 

exponentially in recent years. 

Temperature management during CAB surgery 

Prevention of hypothermia during off-pump CAB (OPCAB) surgery presents 

specific challenges in terms of intraoperative temperature management. The 

Kimberly-Clark Patient Warming System caught my interest when I was in 

conversation with other cardiac surgeons, who reported that this new technology 

compared favourably with the patient warming measures that they were 

already using in CAB surgery. When we then evaluated the existing 

standard of patient temperature management in our surgical unit we were 

surprised to find that we were not routinely achieving normothermia. This was 

an important finding, because maintenance of intraoperative normothermia 

is a part of the integrated care strategy for patients undergoing OPCAB 

surgery in our unit. We consider that maintaining normothermia gives 

patients the best opportunity to benefit from rapid progress from surgery to 

recovery and postoperative stay. So, we evaluated the Kimberly-Clark 

Patient Warming System and found that normothermia was maintained in 

OPCAB surgery patients throughout the surgical procedure and into the postoperative 

period on the intensive care unit (ICU). The system was clearly a 

more effective approach to patient warming than our existing temperature 

management strategy. 

Normothermia allows early or immediate extubation 

Normothermia is one of the criteria for extubation following cardiac surgery, 

and the longer it takes to achieve normothermia in the ICU, the longer the


Testimonial 

patient remains intubated. Successful maintenance of intraoperative 

normothermia, which the Kimberly-Clark Patient Warming System could 

enable us to do, allows us to consider other developments, such as early 

extubation, in the postoperative care of patients who have undergone 

cardiac surgery. Immediate or ‘on-table’ extubation, for example, has been 

demonstrated by other surgical groups. 7–9 Immediate or very early extubation 

is important because it implies that patients have achieved an early return of 

adequate spontaneous ventilation, are haemodynamically stable, warm, 

have adequate analgesia, and therefore do not need to be moved from the 

operating room to the ICU. This would have significant benefits for the patient 

and the healthcare system, with cost savings arising from direct transfer of 

these patients to lower dependency care, where fewer staff are required to 

manage each patient, before moving to the postoperative ward. 

Maximising case throughput while optimising benefits to patients is 

integral to today’s current strategy for healthcare delivery. But, while 

accelerating patient discharge is desirable, there is clearly a limit to how 

soon this can be done. Postoperative surveillance is essential to document 

the absence of any acute complications, after which the patient can be 

safely discharged. Many patients who undergo cardiac surgery are of 

working age, so rapid recovery and return to full functional activity is 

important to them in terms of their earning capacity as well as their health. 

Maintaining perioperative normothermia has a range of beneficial 

effects 

Previous studies have demonstrated numerous benefits from the effective 

maintenance of normothermia in patients undergoing cardiac surgery, 

including: 

■ lower plasma troponin I and risk of myocardial injury 10,11 

■ improved cardiac function 12 

■ lower inflammatory response 11 

■ less perioperative blood loss and transfusion requirement 13–15 

■ reduced intubation time 15 

■ shorter ICU and hospital stays 15 

■ lower postoperative mortality. 13 

It is important to appreciate that the benefits of maintenance of normothermia 

are not restricted to those undergoing cardiac surgery. Prospective 

randomised studies have shown that maintenance of normothermia has a 

range of benefits in general surgical or transplant patients, including 

reduction in blood loss and reduction in myocardial injury. The significant 

haemodynamic and physiological changes created by intraoperative


Testimonial 

hypothermia lead to postoperative myocardial ischaemia, which increases 

the risks of myocardial infarction and cardiac-related death. This risk is 

particularly raised in the many non-cardiac surgical patients undergoing 

surgery who have coronary artery disease. 16 

Deferred or indirect benefits attributable to the maintenance of normothermia, 

such as reduced postoperative wound infection rates have been shown, 17 

and may indicate better preservation of immune system integrity in actively 

warmed patients but further research is needed. 

The need for effective patient warming probably extends to all 

surgical patients 

The Kimberly-Clark Patient Warming System has proved effective in 

on-pump CAB surgery as well as OPCAB surgery and I see no reason why it 

should not be used in a wide variety of cardiac surgical procedures and 

non-cardiac surgical procedures too. Several other types of major surgery, 

such as colorectal surgery or liver transplant, are lengthy procedures during 

which patients can be expected to experience significant temperature 

loss if not actively warmed. But perioperative hypothermia probably affects 

a wider proportion of patients that undergo surgery than one might expect. 

This reflects the fact that, with redistribution of heat from the core to the 

periphery, there is a rapid decrease in core temperature following induction 

of anaesthesia. 18 Patients are thus at risk of mild hypothermia even in 

procedures that last less than one hour from the time of anaesthesia, such as 

day case procedures, in which core temperature is probably not measured 

routinely. If maintaining normothermia improves the functional outcome, as 

well as the patient’s experience, it may increase the proportion of patients 

who are discharged after ambulatory surgery. The clinical utility of the 

Kimberly-Clark Patient Warming System potentially extends to all surgical 

patients at risk of perioperative hypothermia. 

Patient warming systems must not compromise surgical technique 

A prerequisite of any active warming system is that it must allow unrestricted 

access to the operative field; not just the incision site, but catheters, needles 

and drainage tubes. In other words, surgical approach or technique should not 

be modified to suit the patient warming system. One of the disadvantages of 

the previous active warming systems used in our unit was that they could 

not be applied during all of the operation. In cardiac surgery, the thorax, one 

of the upper limbs and perhaps both lower limbs need to be exposed for most 

of the procedure. This leaves the relatively small anterior surface of the body


Testimonial 

for heat exchange. A key advantage of the Kimberly Clark Patient Warming 

System is that by applying thermal pads to the dorsum we can actively warm 

the patient efficiently throughout the whole operation without interfering with 

the surgical process. In addition, the ambient temperature in the operating 

room can be maintained at level that is comfortable for surgical staff, which 

is another important benefit. 

In other surgical fields, there are clearly procedures that require an incision 

on the dorsum. The Kimberly-Clark Patient Warming System provides 

thermal pads in a variety of sizes, so it is almost always possible for pads to 

be placed on a part of the patient that is outside the required surgical field. 

The efficiency of the system is such that only 20% of the body surface area 

is required to impart effective heat exchange to maintain normothermia. 

Previous research has established that temperature management is best 

started prior to induction of anaesthesia. This is because induction is 

accompanied by drop of approximately 1.5°C and it is easier and more 

efficient to prevent hypothermia rather than treat it once established. For 

patients requiring epidural anaesthesia, the thermal pads can not be placed 

on the dorsum, but can also be applied to the ventral aspect of the patient. 

So the system has flexibility that is not so evident with, for example, forcedair 

warming systems. The warming blankets are difficult to position on 

patients and tend to move during surgery. More importantly for our cardiac 

surgery patients is the fact that applying smaller sized warming blankets on 

the lower limbs does not maintain normothermia. 

Hydrogel-filled thermal pads achieve efficient heat transfer 

The adhesive quality of the thermal pads is another important feature of the 

Kimberly-Clark Patient Warming System. With thermal mattresses or blankets, 

the amount of direct contact with the patient is limited, which 

results in lower efficiency of heat transfer. By adapting to the shape of the 

patient, almost the whole surface area of the bio-compatible hydrogel-filled 

thermal pads of the Kimberly-Clark Patient Warming System is in contact 

with the patient. This achieves efficient transfer of heat from the pads to the 

patient and requires contact with a relatively small area of the patient for the 

system to transfer sufficient heat to maintain normothermia. There is a 

consensus in my surgical unit that having an effective warming system in 

place from when the patient arrives in the anaesthetic room through to 

the postoperative period is clearly preferable to using a warming system that 

can be applied only intermittently during the operation.


Testimonial 


1. Cheng DC, Bainbridge D, Martin JE, Novick RJ. Does off-pump coronary artery bypass reduce mortality, morbidity, 

and resource utilization when compared with conventional coronary artery bypass? A meta-analysis of randomized 

trials. Anesthesiology 2005; 102: 188–203. 

2. Raja SG. Pump or no pump for coronary artery bypass: current best available evidence. Tex Heart Inst J 2005; 32: 489–501. 

3. Scott BH, Seifert FC, Grimson R, Glass PS. Resource utilization in on- and off-pump coronary artery 

surgery: factors influencing postoperative length of stay--an experience of 1,746 consecutive patients 

undergoing fast-track cardiac anesthesia. J Cardiothorac Vasc Anesth 2005; 19: 26–31. 

4. Kastanioti C. Costs, clinical outcomes, and health-related quality of life of off-pump vs. on-pump coronary bypass 

surgery. Eur J Cardiovasc Nurs 2007; 6: 54–9. 

5. Bossone E, Di Benedetto G, Frigiola A et al. Valve surgery in octogenarians: in-hospital and long-term 

outcomes. Can J Cardiol 2007; 23: 223–7. 

6. Ott E, Mazer CD, Tudor IC et al. Coronary artery bypass graft surgery--care globalization: the impact of 

national care on fatal and nonfatal outcome. J Thorac Cardiovasc Surg 2007; 133: 1242–51. 

7. Hemmerling TM, Prieto I, Choiniere JL, Basile F, Fortier JD. Ultra-fast-track anesthesia in off-pump 

coronary artery bypass grafting: a prospective audit comparing opioid-based anesthesia vs thoracic 

epidural-based anesthesia. Can J Anaesth 2004; 51: 163–8. 

8. Horswell JL, Herbert MA, Prince SL, Mack MJ. Routine immediate extubation after off-pump coronary 

artery bypass surgery: 514 consecutive patients. J Cardiothorac Vasc Anesth 2005; 19: 282–7. 

9. Edgerton JR, Herbert MA, Prince SL et al. Reduced atrial fibrillation in patients immediately extubated after offpump 

coronary artery bypass grafting. Ann Thorac Surg 2006; 81: 2121-6, 2126–7. 

10. Nesher N, Zisman E, Wolf T et al. Strict thermoregulation attenuates myocardial injury during coronary artery 

bypass graft surgery as reflected by reduced levels of cardiac-specific troponin I. Anesth Analg 2003; 96: 328–35. 

11. Nesher N, Uretzky G, Insler S et al. Thermo-wrap technology preserves normothermia better than routine thermal 

care in patients undergoing off-pump coronary artery bypass and is associated with lower 

immune response and lesser myocardial damage. J Thorac Cardiovasc Surg 2005; 129: 1371–8. 

12. Nesher N, Insler SR, Sheinberg N et al. A new thermoregulation system for maintaining perioperative normothermia 

and attenuating myocardial injury in off-pump coronary artery bypass surgery. Heart Surg Forum 2002; 5: 373–80. 

13. Insler SR, O’Connor MS, Leventhal MJ, Nelson DR, Starr NJ. Association between postoperative hypothermia and 

adverse outcome after coronary artery bypass surgery. Ann Thorac Surg 2000; 70: 175-81. 

14. Hofer CK, Worn M, Tavakoli R et al. Influence of body core temperature on blood loss and transfusion 

requirements during off-pump coronary artery bypass grafting: a comparison of 3 warming systems. J Thorac Cardiovasc 

Surg 2005; 129: 838–43. 

15. Woo YJ, Atluri P, Grand TJ, Hsu VM, Cheung A. Active thermoregulation improves outcome of off-pump coronary 

artery bypass. Asian Cardiovasc Thorac Ann 2005; 13:157–60. 

16. Naughton C, Reilly N, Feneck R. Cardiac disease in the non-cardiac surgical population: effect on survival. Br J 

Nurs 2005; 14: 718–24. 

17. Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and 

shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med 1996; 334: 1209–15. 

18. Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin 2006; 24: 823–37.


Testimonial


Testimonial 


Based on an interview by 

Dr Peer Hofmann, consultant anaesthesiologist, Krankenhaus 

Nordwest, Frankfurt, Germany. 


22 June 2007, at the SAS Radisson Hotel in Reykjavík, Iceland 


New non-pharmaceutical ways to reduce surgical site infections. 

Perioperative patient warming: an anaesthesiologist’s view 

At the 600-bed private hospital in Frankfurt where I am a consultant 

anaesthesiologist, my department has primary responsibility for the 

management of the patient recovering from anaesthesia during the immediate 

post-operative period. This period will usually be up until the time when the 

patient is able to be discharged from the recovery area. In addition, together 

with the other anaesthesiologists, I also share responsibility for patients who 

move to the intensive care unit (ICU) after surgery. It was in the ICU where 

we formerly have seen hypothermia as a consequence of lengthy surgery, 

and occasionally included patients who have had major surgery, deteriorating 

while in the recovery ward and required reintubation and transfer to ICU. 

Active warming systems must be adaptable 

We currently use at least three different devices for perioperative active 

warming. These include the WarmTouch ® (Tyco Healthcare) and the Bair 

Hugger ® (Arizant Healthcare) forced-air warming systems and the recentlyintroduced 

Kimberly-Clark Patient Warming System. Initially, we decided to 

use the Kimberly-Clark Patient Warming System for patients undergoing 

lengthy surgical procedures, such as aortic surgery, or for those cases in 

which the type of surgery meant that it was difficult or not possible to use a 

conventional warming system, such as cosmetical breast surgery for example. 

Our initial experience has been very positive, and we are using the 

Kimberly-Clark Patient Warming System for an increasing variety of types of 

surgery. 

With the forced-air warming systems such as the Bair Hugger or a 

conventional thermal mattress, we rarely had noted cases where the extent 

or position of surgical field left insufficient body surface accessible for 

adequate heat transfer. These patients were then found to be hypothermic 

on arrival in the recovery room and so could not sometimes be extubated.


Testimonial 

Early extubation is a key objective 

There is strong evidence to show that the longer a patient is intubated, 

the higher their risk of acquiring a respiratory infection, particularly for 

patients in ICU 1 . Intubation of the trachea and mechanical ventilation is 

associated with a 7-fold to 21-fold increase in the incidence of pneumonia 

and up to 28% of patients receiving mechanical ventilation will develop VAP 2 . 

Mortality rates among patients with VAP have been reported to be as high as 

72% 3 . Furthermore, hypothermia and intubation both independently add to 

the risk of mortality due to bacteraemic pneumonia 4 . So, it is clear that for a 

patient to remain intubated solely because s/he is hypothermic is unacceptable 

and a situation that we should be able to avoid. 

Awareness of the consequences of unintentional hypothermia is 

not universal. 

Overall, I think the systems and procedures we use for preparing patients 

for surgery and monitoring them through to recovery work well. The 

anaesthesiologists know the importance of active warming to keep patients’ 

core temperature above 36°C and the level of education and supervision that 

our trainees receive is high. The results of a Europe-wide survey that were 

published recently, which showed that under general anaesthesia, temperature 

was monitored in only a quarter of patients and less than half were actively 

warmed 5 together with the growing evidence for the importance of maintaining 

normothermia strengthen the point that hypothermia should be avoided. I 

think that if additional time is taken to properly prepare and maintain patients 

before and during surgery, this is recovered many times over by better postoperative 

progress. 

In terms of routine practice, we consider case by case which patients awaiting 

elective surgery the next day are likely to benefit from active warming – and 

in my opinion, that is most of them. If we decide that active warming is 

indicated and we choose the Kimberly Clark Patient Warming System, this 

will be applied before induction of anaesthesia and remain in place through 

to the patient entering the ICU. The anaesthesiology nurses who are 

responsible for preparing and using the system in the operating room, have 

commented that they have found the system intuitive to operate and overall 

easy to use, based on some 40 surgical cases so far. 

New health technology: cost vs investment 

Clearly, the cost:benefit aspects of any new technology should be considered 

before it is acquired. The Head of the Clinic for Anaesthesiology, Postoperative 

Intensive Care and Pain Therapy at the hospital, Professor Oliver Habler has 

a strong research interest in the haematological aspects of surgical patients, 

So, we were very aware that, for example, patients hypothermic during and


Testimonial 

after surgery have impaired coagulation 6 , increased blood loss and transfusion 

requirements 7–9 . Moreover the rate of surgical wound infection is increased 

in these patients. Thus, the clinical need for active warming systems was 

clear, and we had also recognised that there are some patients who could 

not be warmed adequately by any other approach, so we already had good 

justification for investing in a Kimberly-Clark Patient Warming System. 

Randomised comparative studies reveal differences in efficiency, cost, easeof-use 

and so on between different patient warming devices such the Bair 

Hugger and the Kimberly-Clark systems. 


1. Alp E, Voss A. Annals of Clinical Microbiology and Antimicrobials 2006; 5: 7 doi:10.1186/1476-0711-5-7. 

2. Hunter JD. Ventilator associated pneumonia. Postgrad Med J 2006;82;172–178. 

3. Rello J. Bench-to-bedside review: Therapeutic options and issues in the management of ventilatorassociated 

bacterial pneumonia. Critical Care 2005; 9: 259–65. 

4. Bishara J et al. Seven-year study of bacteraemic pneumonia in a single institution. Eur J Clin Microbiol 

Infect Dis 2000; 19: 926-31. 

5. Torossian A et al. Survey on intraoperative temperature management in Europe. European Journal of 

Anaesthesiology 2007; 24: 668–675. 

6. Kahn HA et al., Hypothermia and bleeding during abdominal aortic aneurysm repair. Ann Vasc Surg 1994; 

8: 6–9. 

7. Schmied H et al. Mild hypothermia increases blood loss and transfusion requirements during total hip 

arthroplasty. Lancet 1996; 347: 289–92. 

8. Winkler M et al. Aggressive warming reduces blood loss during hip arthroplasty. Anesth Analg 2000; 

91: 978-84. 

9. Kumar S et al. Effects of perioperative hypothermia and warming in surgical practice. Int Wound J 2005; 

2: 193–204.

INFECTION ? 

NOT ON MY WATCH. 

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