Significant reduction in incidence of wound contamination by skin flora through use of microbial sealant. A pilot study of the effects of Vivostat patient-derived fibrin sealant in reducing blood loss in primary hip arthroplasty. Prospective randomized study evaluating a biodegradable polymeric sealant for sealing intraoperative air leaks that occur during pulmonary resection. Fibrin sealant reduces the duration and amount of fluid drainage after axillary dissection: a randomized prospective clinical trial. Clinical and microbiologic effects of chemical versus mechanical cleansing in professional supportive implant therapy. Clinical and antibacterial effectiveness of three different sealant materials. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. Oral versus systemic antibiotic prophylaxis in elective colon surgery: a randomized study and meta-analysis send a message from the 1990s. Should antimicrobial prophylaxis in colorectal surgery include agents effective against both anaerobic and aerobic microorganisms? A double-blind, multicenter study. The Norwegian Study Group for Colorectal Surgery.
Application of skin sealant prior to incision reduces microbial contamination of the wound.
                Prospective, randomized, multicenter clinical trial.
                Six teaching hospitals.
                A total of 177 adult patients undergoing elective open inguinal hernia repair were randomized to either standard skin preparation with 10% povidone-iodine or skin preparation followed by cyanoacrylate-based liquid microbial sealant.
                Wound contamination was assessed during surgery by microbial sampling inside the wound at initiation of skin incision and prior to skin closure.
                The primary outcome measures were the safety and effectiveness of cyanoacrylate-based microbial sealant to reduce bacterial contamination during surgery. The secondary outcome measure was reduction of postoperative surgical site infections using microbial sealant.
                Demographics were similar. Patients treated with sealant were more likely to have no bacterial cells found in the wound than control participants (47% vs 31%; P = .04). Three patients developed surgical site infections; all were in the control group (P = .25). Independent factors that reduced wound contamination were use of microbial sealant (odds ratio, 0.45; confidence interval, 0.23-0.88; P = .02) and perioperative antibiotics (odds ratio, 0.24; confidence interval, 0.10-0.58; P = .001).
                Cyanoacrylate-based microbial sealant may be an important tool to reduce wound contamination and potentially prevent surgical site infections. A pilot study evaluated the effectiveness of Vivostat patient-derived fibrin sealant in reducing blood loss in patients who underwent primary hip arthroplasty. Eighty adult patients undergoing elective surgery were randomized to receive either Vivostat sealant or control (no additional hemostatic treatment). Patients allocated Vivostat sealant donated 120 mL of blood, which was then processed perioperatively to produce a fibrin sealant that was applied to the bleeding wound surfaces just before closure. Transfusion requirements, blood loss during surgery, drain volumes, and daily hematocrit and hemoglobin levels were measured. Hospitalization times, adverse events, and postoperative wound complications were also monitored. Blood loss during surgery and wound drainage volume was lower in the Vivostat group than in the control group, although the differences were not significantly different. Transfusion requirements (median, 270 mL of packed red blood cells) and hospitalization times (both median 7 days) were the same for both groups. No adverse events related to the use of Vivostat occurred. There were indications of a possible reduction in the incidence of postoperative wound oozing (15% vs 25%) and hematomas (6% vs 11%) with the use of Vivostat compared with the control group, although differences were not statistically significant. In conclusion, in this pilot study, use of Vivostat patient-derived fibrin in hip arthroplasty was not associated with a significant reduction in blood loss. Further studies, with larger numbers of patients, may be warranted to investigate a possible benefit of Vivostat in reducing postoperative wound complications. To evaluate the safety and effectiveness of a new biodegradable polymeric sealant to close intraoperative air leaks after pulmonary resection.
                In a multicenter prospective randomized trial, 161 patients with a median age of 67 years old (range 18-85 years old), were randomized in a 2:1 ratio to receive sealant or control for at least one significant air leak (> or = 2.0 mm in size) after pulmonary resection. In the sealant group, all significant air leaks underwent attempted repair by standard methods (sutures, staples, or cautery) prior to the application of sealant. The control group underwent only standard methods. Blood was analyzed for immunologic response. Patients were followed up 1 month after surgery.
                Intraoperative air leaks were sealed in 77% of the sealant group compared with 16% in the control group (p < 0.001). The sealant group had significantly fewer patients with postoperative air leaks compared with the control group (65% vs 86%, p = 0.005). Median length of hospitalization was 6 days (range, 3-23 days) for the sealant group compared with 7 days (range 4-38 days) for controls (p = 0.028). There was no difference in mortality, morbidity, duration of chest tubes, or immune responses between the two groups.
                This study demonstrates the effectiveness of a biodegradable polymer when used as an adjunct to standard closure methods for sealing significant intraoperative air leaks that develop from pulmonary surgery. Use of the sealant led to a reduction in postoperative air leaks, which may have decreased the length of hospitalization. Patients who have axillary dissections during lumpectomy or modified radical mastectomy for breast carcinoma accumulate serosanguinous fluid, potentially resulting in a seroma. Currently accepted practice includes insertion of one or more drains for fluid evacuation. This multicenter, randomized, controlled, phase II study was undertaken to evaluate whether a virally inactivated, investigational fibrin sealant is safe and effective when used as a sealing agent to reduce the duration and volume of serosanguinous fluid drainage and to determine the dose response of this effect.
                Patients undergoing lumpectomy or modified radical mastectomy were randomized to treatment with 4, 8, or 16 mL of fibrin sealant or control (no agent) at the axillary dissections site. Patients undergoing modified radical mastectomy also received an additional 4 or 8 mL of fibrin sealant at the skin flap site. Efficacy was evaluated by the number of days required for wound drainage and the volume of fluid drainage compared with control. Safety was confirmed by clinical course, the absence of viral seroconversion, and no major complications attributable to the sealant.
                The 4-mL axillary dissection dose of fibrin sealant significantly reduced the duration and quantity of fluid drainage from the axilla following lumpectomy (p < or = 0.05). In the modified radical mastectomy patients, a 16-mL axillary dissection dose combined with an 8-mL skin flap dose was significantly effective in reducing the number of days to drain removal (p < or = 0.05) and fluid drainage (p < or = 0.01). There were no fibrin sealant patient viral seroconversions and no major complications attributable to the sealant. A number of wound infections were noted, although this may represent a center-specific effect.
                Application of fibrin sealant following axillary dissection at the time of lumpectomy or modified radical mastectomy can significantly decrease the duration and quantity of serosanguinous drainage. The viral safety of the product was also supported. The aim of the present study was to compare the cleansing properties of mechanical supportive care for dental implants with the use of an etching gel. Sixteen patients underwent a 5-month clinical trial with monthly recalls. These patients, wearing maxillary complete dentures and mandibular overdentures supported by a bar device on 4 implants, were treated in a split-mouth study design. Test and control therapy were randomly assigned to left and right sides of the mandible. At the test side, 35% phosphoric etching gel (pH 1) was applied in the peri-implant sulcus. After 1 minute, the sulcus was thoroughly rinsed with a water spray for approximately 15 seconds per implants. Control therapy consisted of supra- and subgingival debridement using carbon fiber curettes and a rubber cup. Plaque, calculus, probing pocket depth, and modified Gingival Index were determined before each treatment. Microbiologic evaluation was performed at baseline, 1 month later, and 5 months later, just before and immediately after each treatment. Per treatment and per assessment, the mean scores of all clinical parameters were calculated for each patient. The number of colony-forming units was used as the primary efficacy variable in the analysis of microbiologic data. At baseline, no differences between test and control sites were observed for any of the clinical parameters. The mean Gingival Index and the mean probing pocket depth were reduced over the 5-month period. The mean reduction in Gingival Index at the test sites proved to be significantly larger at the control sites (P = .03). Both treatment modalities resulted in an instant reduction of the number of colony-forming units, where the reduction by chemical cleaning was larger (P < .05). This short-term study employing a high recall frequency indicates that local application of 35% phosphoric acid gel can be as effective as conventional mechanical supportive therapy. The aim of this work is to study and compare the retention rate, caries-preventing and antibacterial effects of resin-modified glass ionomer and flowable composite in comparison to conventional fissure sealant.
                Forty-five children aged 7-10 years with newly erupted lower first permanent molars were randomly divided into three equal treatment groups. Group I: sealed by a conventional resin sealant; Group II: sealed by resin modified glass ionomer (RMGI); and Group III: sealed by flowable composite. Retention and caries status of the sealed teeth were recorded after 1 month, 6 months, year and 2 years. In addition, Streptococcus mutans counts were assessed at baseline, 1 day, 1 month, 6 months, 1 year and 2 years after sealant application. Data were analyzed by Fisher exact, chi-square and ANOVA tests.
                Group III and Group I showed significantly higher retention rates than Group II fissure sealant (p<0.05). There were no differences of the caries-preventive effects between the tested sealant materials throughout the duration of the study. Streptococcus mutans counts were significantly lower in group II compared to group I or group III up to 6 months of the study (p<0.05). After 1 year of the study the differences of Streptococcus mutans counts were not significant (p>0.05).
                This study indicated a lower retention of RMGI compared to flowable composite and resin sealant without significant difference in caries prevention or long-term bacterial inhibition. A phase-III trial that included fifty-three patients undergoing unilateral primary total knee arthroplasty with cement was conducted to investigate the hemostatic efficacy of fibrin sealant.
                Following cementing of the joint, 10 mL of fibrin sealant was sprayed onto the wound before tourniquet deflation and wound closure. No placebo was used in the control group. All patients received drains.
                Within twelve hours after the surgery, the amount of bloody drainage was 184.5 +/- 28.9 mL (mean and standard error) in the fibrin-sealant group (information available for twenty-three patients) and 408.3 +/- 54.6 mL in the control group (information available for twenty-three patients) (p = 0.002, after adjustment for variance in the time that the drainage was measured). On the first postoperative day, the hemoglobin level had decreased by 20.1 +/- 2.1 g/L in the fibrin-sealant group (information available for twenty-two patients) and by 27.3 +/- 2.1 g/L in the control group (information available for twenty-four patients). After adjustment for baseline values, the decrease in the hemoglobin level was 28.9% less in the fibrin-sealant group than in the control group (p = 0.005, 95% confidence limits = 10.2, 43.7). There were no seroconversions in the fibrin-sealant group.
                These results suggest that fibrin sealant can safely reduce bloody drainage following total knee arthroplasty while maintaining higher hemoglobin levels. To compare the efficacy of combined oral and systemic antibiotics (combined) versus systemic antibiotics (systemic) alone in preventing surgical site infection in elective surgery of the colon, and to perform a meta-analysis of randomized studies comparing combined versus systemic antibiotics in elective colon surgery.
                A double-blind, placebo-controlled, randomized clinical trial.
                The Queen Elizabeth Hospital, Montreal, a university-affiliated community hospital.
                Two hundred and fifteen patients scheduled to undergo elective surgery of the colon.
                Patients were randomized to receive neomycin and metronidazole orally (109 patients) or identical placebos (106 patients) on the final preoperative day. All were given amikacin and metronidazole intravenously just before operation. Thirteen randomized series comparing combined and systemic antibiotic prophylaxis in elective colon surgery were identified for meta-analysis.
                Rates of postoperative surgical site infections: risk differences, risk ratios (RRs) and 95% confidence intervals (CIs); organisms found in the colon and wound fat at surgery, and in infected wounds.
                Three patients in the systemic group, and 5 in the combined group were excluded. Wound infections occurred in 5 patients in the combined group but in 17 in the systemic group (p < 0.01, RR = 0.29, 95% CI 0.11-0.75). Bacteria isolated from wound infections and wound fat were similar to those found in the colon. They were more frequent in the colon in the systemic group (p < 0.001) and occurred in wound fat in the systemic group twice as often as in the combined group (p < 0.001). By stepwise logistic regression, the presence of bacteria in wound fat at surgery was the strongest predictor of postoperative wound infection (p < 0.002). In the meta-analysis, the summary weighted risk difference in surgical site infections between groups (d(w)) and the summary RR both favoured combined prophylaxis (d(w) = 0.56, 95% CI 0.26-0.86; RR = 0.51, 95% CI 0.24-0.78; p < 0.001).
                In elective surgery of the colon combined oral and systemic antibiotics are superior to systemic antibiotics in preventing surgical site infections. Orally administered antibiotics add value by reducing bacterial loading of the colon and wound fat contamination, both associated with postoperative wound infection. Meta-analysis of randomized clinical trials reported from 1975 to 1995 supports these conclusions. It is now well demonstrated that a mixed flora of aerobic and anaerobic microorganisms will be found in wound abscesses and peritonitis after bowel surgery. An impressive reduction in infectious complications caused by anaerobic microorganisms can be achieved with nitroimidazole prophylaxis, but considerable uncertainty about the role of agents active against aerobic microorganisms in such prophylaxis still exists. We have earlier reported that a single dose of tinidazole and doxycycline significantly reduces postoperative infections and is superior to doxycycline alone. The effect of an agent active only against anaerobic microorganisms was tested in a double-blind study of 267 patients who underwent elective colorectal surgery. The patients received either tinidazole (1600 mg) and placebo or tinidazole (1600 mg) and doxycycline (400 mg) as a single preoperative infusion. Patients who received tinidazole and doxycycline had significantly fewer infectious complications, reoperations, additional use of antibiotics, and a shorter hospital stay. Microbiologic studies demonstrated that tinidazole alone gave effective protection against anaerobic organisms but did not protect the patients from aerobic gram-negative infectious complications. A single preoperative dose of antimicrobial agents effective against both anaerobic and aerobic bowel organisms seems to be the preferred prophylaxis for patients undergoing colorectal surgery.
There is currently insufficient evidence as to whether the use of microbial sealants reduces the risk of surgical site infection in people undergoing clean surgery and further rigorous RCTs are required.