Several Surgical site infection (SSI) prevention guidelines have been published over the last
10 years. Topical prophylaxis of the surgical wound with antibiotics or antiseptics is one of
the most controversial measures proposed for SSI prevention. Two guidelines (British, Spanish
Ministry of Health) explicitly recommend not irrigating surgical wounds with any product. The
World Health Organization considers irrigation with antibiotics as an unresolved issue and,
together with the Centers for Disease Control, recommends irrigation with a solution of
povidone iodine. The other four guides do not mention the measure. In Catalonia, a SSI
prevention bundle recommends wound irrigation with saline, with a low level of
recommendation.
Therefore, topical prophylaxis with operational wound washings with different solutions has
been poorly studied, evokes contradictory recommendations and is not included in the majority
of clinical practice guidelines for SSI prevention.
However, a high level of use of wound irrigation at the end of an intervention in actual
clinical practice has been observed. In a survey conducted by 2017 and answered by 845
general surgeons of the Spanish Association of Surgeons, before closing the skin, most
surgeons (80.6%) irrigate the subcutaneous layer of the wound, either with saline (51.2%), an
antiseptic solution (23.8%) or an antibiotic solution (1.5%). Only 19.4% of respondents do
not irrigate. In another survey in 2018, focused on colorectal surgeons of two Spanish
associations, similar rates of irrigation with saline, antiseptic or antibiotic were used
(55%, 28.9% and 2.2%, respectively).
SSI rates after complex incisional hernia repair are higher than previously reported. In a
recent paper, this research team observed that patients with SSI after hernia repair showed
more prolonged surgical procedures, and a higher one-year recurrence rate. Multivariable
analysis revealed the only identified risk factor for SSI to be post-operative
sero-hematomas. Patients who developed an SSI required antibiotic agents and daily treatment
from one to five months. One of these required the removal of the mesh. SSI rates were high
for incisional hernia surgery (16%), and were associated with local complications.
The hypothesis of the study is that topical prophylaxis of the surgical wound with irrigation
with an antibiotic solution decreases the rate of postoperative infection in patients
undergoing incisional hernia surgery with different levels of contamination.
The study will compare the efficacy of topical prophylaxis with saline with a solution of
amoxicillin-clavulanate in the incidence of SSI in incisional hernia repair.
It is a randomized, controlled, multicenter, blind study by observer and patient, with two
parallel study groups, phase IV.
Design of study The irrigation of the wound with 0.9% saline will be compared with the
irrigation with an active principle solution of a pharmaceutical specialty of proven efficacy
(amoxicillin-clavulanate) by parenteral route, administered topically and dissolved in
saline.
The two groups of the study will be named: Study Group (irrigation with antibiotic solution)
and Control Group (irrigation with saline).
The project has received the Spanish Drug Agency authorization as a low intervention study, a
grant from the Spanish Ministry of Health and the Ethics Committee authorization of the
Hospital General of Granollers.