An Attempt to Standardize the Protocol for Controlled Study in Postoperative Infections

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No standard form of protocol for assessment criteria in the chemotherapy of infections has been well established in the field of surgery. This report describes an attempt to establish a good protocol for clinical assessment ofchemotherapeutic agents in postoperative infections based on a comparative clinical study of cefotiam and cefazolin.<BR>In order to secure reasonably homogeneous subgroups of subjects who would vary with respect to the symptoms and signs as well as the required duration of chemotherapy, the following categorical criteria for patient selection and stratifi-cation were provided: those with postoperative superficial purulent infections (stratum A); and those with postoperative localized peritonitis and/or dead space infections (stratum B), excluding those connected with an opened lumen of diges-tive tract. The duration of chemotherapy was determined to be 7 days for stratum A and 14 days for stratum B. As targets of observation, 8 items for stratum A and 11 for stratum B were selected among the symptoms and signs considered to be observable with high incidence in the patients of each respective stratum. The surgeons in charge were responsible for observing each patient by using these items throughout the trial and for judging the general outcome of the treatment.<BR>The data obtained from 89 stratum A patients and 79 stratum B patients Were subjected to the statistical analyses. Tentative criteria for grouping the observation items were established from the results of principal component analysis and cluster analysis, after which regression analysis was carried out on the data of these groupings and the overall impressions of the surgeons. Changes in suppurative discharge, local signs, fever, WBC, and abdominal signs (stratum B only) were found to correlate with the overall impressions. From these facts tentative criteria for overall assessment of the chemotherapy were adopted.<BR>When the patients who showed marked discrepancies between their surgeons' judgements and the results based on the criteria were examined, some minor cor-rections were found to be called for with regard to the criteria for patient selection, stratification and overall assessment.<BR>Changes in clinical isolate (s) from the inflammatory focus highly correlated with the alterations in discharge. This fact indicates that bacteriological examination of clinical isolates is also indispensable in the clinical evaluation of chemotherapeutic agents in postoperative surgical infections.

An Attempt to Standardize the Protocol for Controlled Study in Postoperative Infections

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