The Effect of an Enhanced PerOperative Care and Health Protection
Programme on Surgical Site Infections (SSI) after elective
abdominal surgery

Surgical site infections (SSI) are common after surgery and a major cause of
morbidity and mortality, prolonged hospital stay and healthcare costs. SSI
often require long and extremely painful wound care and cause a lot of
unnecessary pain, fear disability and even death. As with many iatrogenic
problems, they disrupt the expectation that health care will be reparative,
recuperative or healing and instead involve the patient in suffering an
additional burden of pain and impairment: it interrupts the expected progress
towards health recovery[1]. Patients report a sense of violation or betrayal
having contracted an infection while in the hospital[2] as well as a loss in
confidence in health service and a dread of going back[3]. In the Netherlands,
of all operated patients 3.9% suffer from an SSI. In gastrointestinal surgery
up to 9.3% of all patients encounter a SSI[4]. SSI account for 33% of all
healthcare-associated infections (HAIs)[5].
SSIs are not always avoidable but approximately 55% of SSI are deemed
preventable with evidence based strategies[6]. However it has become apparent
that improvement of individual measures alone is unlikely to result in a
clinically relevant effective SSI reduction[7-9]. In contrast, efforts that
have used systematic approaches, or bundles, have been successful to varying
degrees[10-12]. The care-bundle concept was developed by the Institute for
Healthcare Improvement in 2001[79]. Two commonly used and successful
application of this approach are the care bundles developed to reduce central
venous catheter-line infection and to reduce ventilator associated pneumonia
[79]. The Surviving Sepsis Campaign has used the care-bundle concept to improve
dramatically the outcomes of patients presenting with sepsis[80]. The Dutch
guideline dictates use of the POWI (PostOperative Wound Infection) bundle which
includes hygiene discipline (focusing on door movements), timing of antibiotic
prophylaxis, normothermia, and no preoperative hair removal[13].
1. There is scarce evidence of this bundle*s effect. A national reduction in
SSI has not been demonstrated since implementation[14].
2. In this current bundle only maintaining normothermia (1 out of the 4 POWI
bundle measures) has published evidence of being effective in reducing SSI in
recent systematic reviews[15-18]. All other 3 measures in the bundle (limited
door movements, timing of antibiotic prophylaxis and no preoperative hair
removal) are not significantly associated with a reduction in SSI[19-21].
Current evidence suggests that perioperative care can be optimized beyond this
bundle. Other risk factors for the development of SSI, that can be targets of
intervention, have shown to be of greater importance than 3 of the 4 POWI
bundle components. However, budgets are tight and new investments are not
always feasible. We need a set that includes readily available interventions
targeted to modifiable risk factors that have a proven effect on SSI.
In this study design, in collaboration with (a) international experts and (b)
the WHO, and (c) through consensus with participating centers, we formulated an
enhanced perioperative care program (EPOCH) comprising evidence based
interventions readily applicable without introduction of new material to reduce
SSI, to be added on top of usual care.

Our primary objective is to evaluate the effect of an enhanced perioperative
care program added on to usual care on the incidence of SSI. Secondary
objectives are to evaluate SSI rate at 3 months follow-up, assessment of health
and disability with the WHO disability assessment schedule 2.0 and direct and
indirect medical and non-medical costs and readmission rates.

As an additional objective we will try to assess the attributive effect on our
primary endpoint of the separate components of the current POWI bundle and
promising innovative interventions, applied in some practices, outside the
bundle under investigation . This will help us to separate benefit from ballast
within the current perioperative practice. Ultimately this will contribute to a
concise bundle of interventions comprising the effective interventions of
current practice and our innovative bundle when proven effective.

Pragmatic, randomized controlled parallel-group multicenter superiority trial
that compares an enhanced (optimized) perioperative care and health protection
program combining evidence-based methods to usual care. Randomization will be
performed daily per hospital to prevent contamination between groups. To
safeguard adherence and persistence tot the study protocol weekly reminders
will be sent to anesthesiologists and surgeons, random periodic controls visits
to the operating theaters will be made throughout the study duration and a
self-score checklist about the interventions after every operation have to be
filled out by both surgeon and the anesthesiologist

An evidence-based, enhanced perioperative care program that can be applied
without introduction of new material in the OR, added to usual care, comprising:
1. Normothermia
- Active perioperative warming
2. Supplemental oxygen (hyperoxygenation)
- FiO2 80%
3. Normovolemia
- Goal directed therapy
4. Normoglycemia
- Blood glucose <10mmoll-1
5. Surgical site handling.
- Alchol based antiseptic
- Dilute PVI/CHX wound irrigation prior to closure

For participants of the additional measurements in the AMC: The aminolevulinic
acid patch may lead to temporary local side effects at the site of the patch,
including irritation, burning sensation, and erythema.