Autologous Platelet-Leukocyte Gel Therapy during sternum closure in cardiac surgery patients at risk for post-operative infection.

From literature, it is estimated that up to 9% of the cardiac surgical patients
will experience a sternal wound infection during the first 90 days after
surgery. In this study, patients with all-cause cardiac surgery and at least 2
risk factors for sternal wound infection will be included. It is estimated that
having at least 2 riskfactors will increase the risk of infection with a
factor 2-3. This risk of infection might be reduced by locally applying
Autologous Platelet-Leukocyte Gel (APLG),which will be derived from the
patient*s own blood. Platelets and leukocytes in the gel release growth factors
that induce wound healing and prevent infection. Furthermore platelets form
plugs thereby possibly reducing postoperative blood loss. APLG will also be
applicated in vessel harvest sites to reduce te risk of vessel harvest sites
infection.

To investigate whether application of APLG will lead to reduction in:
1) sternal wound infections
2) vessel harvest site infections
3) postoperative blood loss
4) postoperative pain

A prospective, randomized, single blinded mono-center study

Patients randomized to the APLG group will receive APLG in the sternal wound,
and if graft material is harvested, to the harvest site wound(s) as well. From
each patient approximately 20% of circulating bloodvolume will be collected at
the beginning of the surgery. From this blood the APLG will be processed by one
of the perfusionists. A large amount of this blood, which will remain after
producing APLG, will be returned as erythrocyte concentrate at the end of the
operation.

For each patient enrolled in the study, information will be collected during
hospitalisation (including surgery) and during the standard post-operative
control visit. Only the visit 90 days after surgery is extra, during which
only information will be collected.

Theoretically blood(products) are at risk for bacterial contamination during
preparation and application. Because APLG is being produced in an aseptic way
during operation, the risk of infection is estimted as very low. From
literature and our own experience we know that producing and application of the
gel is safe.