Feasibility of subcutaneous gentamicin and pressurized irrigation as adjuvant strategies to reduce surgical site infection in colorectal surgery: results of a pilot study.

Surgical site infections (SSIs) remain a common and costly morbidity after colorectal surgery. This rate remains high even in the setting of strict adherence to Surgical Care Improvement Project Protocols. The aim of our pilot study was to determine the feasibility and safety of subcutaneous gentamicin injection or pressurized irrigation as adjuncts to reduce SSI. A total of 132 patients who underwent colorectal surgery at the VA North Texas Health Care System were prospectively assigned to a pressurized irrigation group (n = 44), a preincision gentamicin injection group (n = 48), or control (n = 40). The primary objective was to assess safety and feasibility of these strategies. Patient demographics were matched among groups. Univariate and multivariate analyses were performed to identify possible predictions of SSI in this cohort. The rate of SSI in the control group was 25 per cent, 13.5 per cent in the pressurized irrigation group, and 12.5 per cent in the gentamicin group (P = 0.26). Combined, the intervention groups had a 13 per cent SSI versus 25 per cent control (P = 0.09). Operative time was not increased by the interventions and no intraoperative complications specifically related to the interventions were noted. Postoperative complications were not different between groups. Both albumin and body mass index were associated with SSI. Body mass index was and independent predictor of SSI (P = 0.006). In conclusion, this pilot study demonstrates the feasibility of the interventions described. There was no detrimental effect of either intervention. There was trend toward a reduction in SSI in the intervention group, which warrants further investigation.

Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial.

OBJECTIVE: To determine if an evidence-based practice bundle would result in a significantly lower rate of surgical site infections (SSIs) when compared with standard practice. DESIGN: Single-institution, randomized controlled trial with blinded assessment of main outcome. The trial opened in April 2007 and was closed in January 2010. SETTING: Veterans Administration teaching hospital. PATIENTS: Patients who required elective transabdominal colorectal surgery were eligible. A total of 241 subjects were approached, 211 subjects were randomly allocated to 1 of 2 interventions, and 197 were included in an intention-to-treat analysis. INTERVENTIONS: Subjects received either a combination of 5 evidenced-based practices (extended arm) or were treated according to our current practice (standard arm). The interventions in the extended arm included (1) omission of mechanical bowel preparation; (2) preoperative and intraoperative warming; (3) supplemental oxygen during and immediately after surgery; (4) intraoperative intravenous fluid restriction; and (5) use of a surgical wound protector. MAIN OUTCOME MEASURE: Overall SSI rate at 30 days assessed by blinded infection control coordinators using standardized definitions. RESULTS: The overall rate of SSI was 45% in the extended arm of the study and 24% in the standard arm (P = .003). Most of the increased number of infections in the extended arm were superficial incisional SSIs (36% extended arm vs 19% standard arm; P = .004). Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk (95% confidence interval, 1.36-4.56; P = .003) independent of other factors traditionally associated with SSI. CONCLUSIONS: An evidence-based intervention bundle did not reduce SSIs. The bundling of interventions, even when the constituent interventions have been individually tested, does not have a predictable effect on outcome. Formal testing of bundled approaches should occur prior to implementation.

Surgical site infections after colorectal surgery: do risk factors vary depending on the type of infection considered?

BACKGROUND: The purpose of this study was to compare risk factors for the development of incisional versus organ/space infections in patients undergoing colorectal surgery. METHODS: An institutional review board-approved retrospective review was performed examining a 4-year period (January 2002 to December 2005). Patients were included if they had undergone abdominal operations (open or laparoscopic) in which the colon/rectum was surgically manipulated. Patients were excluded if the surgical wound was not closed primarily. A standardized definition of incisional and organ/space infection was employed. RESULTS: A total of 428 operations were performed. Overall, 105 infections were identified (25%); 73 involved the incision and 32 were classified as organ/space. Multivariate analysis suggested that incisional infection was independently associated with body mass index (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.02-1.11) and creation/revision/reversal of an ostomy (OR, 2.2; 95% CI, 1.3-3.9). Organ/space infection was independently associated with perioperative transfusion (OR, 2.3; 95% CI, 1.1-5.5) and with previous abdominal surgery (OR, 2.5; 95% CI, 1.2-5.3). CONCLUSIONS: Factors associated with infection differed based on the type of surgical site infection being considered. The lack of overlap between factors associated with incisional infection and organ/space infection suggests that separate risk models and treatment strategies should be developed.

Transmetatarsal amputation: assessment of current selection criteria.

BACKGROUND: Transmetatarsal amputation (TMA) is an operation designed to remove a limited area of irremediable tissue ischemia and/or infection and preserve limb function. Patients are selected for TMA based on degree of tissue loss/infection, adequacy of tissue perfusion at the transmetatarsal level, current ambulatory status, and estimation of the likelihood of postprocedure ambulation. The purpose of this study was to assess the validity of these selection criteria. METHODS: An institutional review board-approved retrospective review was conducted of all patients undergoing TMA from January 1, 1997, until January 1, 2006. Information was collected on patient demographics, medical comorbidity, and clinical and surgical variables. Outcome measures included the proportion of patients requiring amputation revision to a more proximal level and ambulatory status at last follow-up. RESULTS: Fifty-two TMAs were performed. In 35 procedures, the skin was left open, and in 17 TMA was closed primarily. Primary indications for the procedure were vascular insufficiency or infection in 50 of 52 patients, whereas 2 patients required amputation for malignancy. The majority (46/52, 89%) of patients were diabetic. After the index TMA, 85 additional operations were required. Only 9 patients (18%) underwent a single operation. Revision of the TMA to a more proximal level was required in 29 of 52 (56%) patients, resulting in 4 Syme, 20 transtibial, and 5 transfemoral amputations. Non-insulin-dependent diabetes was associated with an increased likelihood of revision to a more proximal amputation (odds ratio [OR] = 5.4; 95% confidence interval [CI], 1.2-24). At the time of last follow-up (median 18 months), 37 of 50 (74%) patients were ambulatory (83% for TMAs and 67% for more proximal amputations, P = 0.18). Prior vascular procedures were associated with a significantly decreased likelihood of ambulation (OR = 14; 95% CI, 1.9-103). CONCLUSIONS: Although most patients retain the ability to ambulate after TMA, multiple operations should be anticipated in the majority of patients and revision of a TMA to a more proximal level may be required. These data suggest that current selection criteria for TMA may be inadequate.

Correlation between ankle-brachial index, symptoms, and health-related quality of life in patients with peripheral vascular disease.

OBJECTIVE: Improving health-related quality of life (HRQL) is the main goal of surgery to treat peripheral vascular disease (PVD); however, HRQL is rarely measured directly. Rather, most surgeons use other measures, such as patient symptoms and ankle-brachial index (ABI) to determine the need for intervention in PVD. The accuracy of these surrogates in representing HRQL has been untested. The purpose of this study was to determine the correlation of these measures with HRQL in patients undergoing evaluation for intervention in symptomatic PVD. METHODS: Patients (n=108) referred to the vascular surgery service with symptoms of PVD were enrolled in a prospective study of HRQL. Patients completed two validated HRQL questionnaires: the short form-36 (SF-36) and the Walking Impairment Questionnaire (WIQ). All patients had symptoms consistent with PVD, including claudication (n=69; 63.9%), ischemic rest pain (n=17; 15.7%), or tissue loss (n=22; 20.4%). ABI was measured at presentation. RESULTS: The mean ABI was 0.53 (range, 0.00-0.98). The maximal correlation between SF-36 score and ABI was reflected in the Physical Component Summary score (r=0.25). WIQ score also exhibited modest correlation with ABI, with maximal correlation noted for stair climbing (r=0.26). Both SF-36 and WIQ scores exhibited a highly significant association with symptoms. Patients with more severe symptoms, such as lifestyle-limiting claudication or limb-threatening ischemia, had lower HRQL scores compared with patients with non-lifestyle-limiting claudication. Multivariate analysis demonstrated that SF-36 and WIQ physical summary scores are better predicted by symptoms than by ABI (P<.01). CONCLUSIONS: HRQL in patients with PVD correlates weakly with ABI, but exhibits a closer association with vascular symptoms. However, neither variable fully expresses patient HRQL. These data suggest that sole reliance on these surrogates may not accurately reflect the effect of PVD on HRQL, or the potential benefit of vascular surgery in improving HRQL.

Surgical complications exert a lasting effect on disease-specific health-related quality of life for patients with colorectal cancer.

BACKGROUND: For individual patients with colorectal cancer, health-related quality of life (HRQL) after treatment is a function of several factors that include preexisting medical conditions, the disease burden, and the treatment that is rendered. The purpose of this study was to identify the factors that were associated with posttreatment HRQL. METHODS: At baseline and again at 12 months after diagnosis, patients completed the colorectal cancer-specific HRQL survey: Functional Assessment of Cancer Therapy (FACT-C). Univariate and multivariate analyses were performed to test the association between patient-, tumor-, and treatment-related variables and 12-month FACT-C total scores. RESULTS: Seventy-one patients completed the FACT-C at diagnosis and subsequently underwent open surgical removal of their primary tumor; 63 patients completed the 12-month survey. In univariate analysis, only chronic obstructive pulmonary disease at diagnosis or the occurrences of perioperative complications were associated with a reduction in 12-month HRQL scores. Considering both the diagnosis of chronic obstructive pulmonary disease and the occurrence of perioperative complications, along with the patient's FACT-C total score at diagnosis, age, tumor location, and stage of disease in a multivariate model, only the perioperative complications (odds ratio, 10.5; 95% CI, 2.1-52) and FACT-C total score at diagnosis (odds ratio, 1.04; 95% CI, 1.005-1.07) were associated significantly with a lower than median HRQL score at 12 months. CONCLUSIONS: For patients who undergo treatment of colorectal cancer, HRQL at 1 year after diagnosis is still influenced significantly and negatively by the occurrence of surgical complications.