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Effect of Polyhexanide on the Incidence of Surgical Site Infections After Colorectal Surgery.
Hannes P. Neeff*, Mueller S. Anna, Philipp A. Holzner, Guido Wolff-Vorbeck, Ulrich T. Hopt, Frank Makowiec
Department of Surgery, University of Freiburg, Freiburg, Germany
Introduction: Surgical site infections (SSI) are encountered in every surgical practice especially in colorectal surgery. With SSI rates being higher than 20% in colorectal surgery various attempts have been made throughout the history of surgery in oder to reduce SSI. Polyhexanide, which is used for wound cleaning in chronic wounds as well as in orthopedic and trauma surgery, may prove to be useful on the prevention of SSI.
Methods: This study was conducted as a double blind, randomized, single center study with two arms using polyhexanid 0.04% solution for wound irrigation before final wound closure as the treatment arm vs. wound irrigation with ringer’s solution as control. The study was approved by the local ethics committee Albert Ludwig University Freiburg No. 182/10. Primary endpoint was the rate of SSI in each group. Interim analysis was done after 250 patients were screened and is presented here. Patients were stratified according to the underlying disease, surgical access (laparoscopic vs. open) age, gender, smoking history, BMI and others. A total number of 197 elective colorectal resections were randomized. 101 patients received verum. Univariate analysis was followed by multivariate analysis where appropriate.
Results: There were 41 wound infections in 197 patients (20.8%). 19 in the verum group, 22 in the control group (p=0.478). Demographics and risk factors were distributed equally between the two groups. There was a highly significant difference in the rate of SSI correlating with the underlying disease (increasing order: non malignant (n=37), inflammatory, (n=39) malignant (n=107) or chronic inflammatory disease (n=14) (p<0.07)) as well as the surgical access (laparoscopic vs. open, p<0.001). Smoking, BMI >25, age, gender showed no influence on wound healing. Multivariate analysis showed only a difference between open and laparoscopic surgery independent from the underlying disease (RR 2.77, CI 1.34-5.71)
Conclusions: Polyhexanide as a topical wound cleaning agent did not show any benefits when compared to ringer’s solution for the whole group. Subgroup analysis rather showed that underlying non-malignant disease and especially laparoscopic technique decrease the incidence of SSI at our center. However, overall SSI are still high at 20.8% of elective colonic resections included in this study.
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