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Clinical evaluation of B-domain deleted recombinant factor VIII in previously untreated patients.

The safety and efficacy of B-domain deleted recombinant factor VIII (BDDrFVIII) were evaluated in previously untreated patients (PUPs) with severe hemophilia A. In an open-label multicenter study, 101 PUPs received routine prophylactic and/or on-demand treatment with BDDrFVIII, including treatment related to surgery for 50 exposure days for up to 5 years. The pharmacokinetic measurements (ie, elimination half-life and in vivo mean recovery) assessed at baseline and 12 months were stable for BDDrFVIII over time. A total of 1,362 hemorrhages occurred. Ninety-two percent (1,258/1,362) of bleeding episodes resolved after three infusions or fewer. Of the 2,375 infusions rated by investigators, 93% (2,215/2,375) were rated as providing an "excellent" or "good" response. Twenty-seven patients received routine prophylactic treatment, which significantly reduced breakthrough bleeding episodes by twofold when compared with patients who were treated on-demand. Administration in conjunction with 40 surgical procedures showed no adverse effects, and the overall assessment was either "very useful" or "useful." The mean dose was 56 IU/kg for routine primary prophylaxis and 53 IU/kg for on-demand therapy for bleeding episodes in patients who were assessed to be inhibitor-free at the time of infusion. Thirty-two percent of patients developed inhibitors. Of these, 16 patients were high responders (peak titer > or = 5 Bethesda units [BU]). The inhibitor risk was comparable to that seen with full-length recombinant products. BDDrFVIII was found to be effective, safe, and well tolerated.

Antibodies, Viral↗

A small dose of droperidol decreases postoperative nausea and vomiting in adults but cannot improve an already excellent patient satisfaction.

BACKGROUND: We evaluated whether or not 1) a routine prophylaxis with 20 microg x kg(-1) body weight of droperidol would efficiently prevent postoperative nausea and vomiting (PONV) after elective surgery in adults and 2) an efficient prophylaxis would improve patient satisfaction. METHODS: With approval of the local ethics committe and after having obtained informed written consent, 1334 patients in a randomised, single-blinded fashion either received droperidol (group 1, n=665) or saline intravenously (group 2, n=669) 20 min before the end of a standard O2/N2O/fentanyl/isoflurane anaesthesia of at least 30 min duration. END POINTS: incidence of PONV during the first 24 h; individual episodes of nausea or vomiting, overall patient satisfaction with the procedure. RESULTS: Compared to saline, intravenous injection of droperidol substantially and significantly reduced the incidence of PONV from 30% to 20% (P<0.0001). Women suffered three times more frequently from PONV (10.5% vs. 30%, P<0.0001). Droperidol significantly reduced the incidence of PONV from 35.4% to 24.4% in women (relative risk reduction: 31%, P=0.0002), but not in men (13.1% vs. 8.2%, relative risk reduction: 37%, P=0.159)--without impact on overall patient satisfaction (98.8% vs. 97.1%, P=0.439). Distribution of surgical procedures, sex, age, height, weight and anaesthetic duration were not different between groups. To prevent one woman from suffering PONV, nine had to be treated prophylactically at an individual drug cost (German prices) of about Euro0.80 per woman. CONCLUSION: Routine PONV prophylaxis with 20 microg x kg(-1) body weight of droperidol is cost-efficient and appropriate in women but not in men.

Adult↗

Malignant melanoma. Practical considerations concerning prophylactic regional lymph node dissection.

Seventy-three patients had 77 prophylactic regional lymph node dissections (PRLND) in addition to wide excision of the primary lesion for clinical Stage I primary malignant melanoma. The preoperative evaluation, surgical procedure, and postoperative follow-up were performed by one surgical oncologist. Seven patients had micrometastatic disease in the regional nodes for a yield of 9.6%. Considering only patients with Clark IV and V melanomas, and Clark III melanomas greater than or equal to 2.00 mm, the yield was 15.6%. The most optimistic, published survival statistics demonstrate a 25% 5-year survival advantage for patients who have PRLND with an incidence of occult nodal disease of 14.3%; thus, even the most optimistic data would predict that only a modest number of patients would actually benefit from surgery. It is difficult to justify PRLND for its therapeutic benefit unless a higher yield of positive-node patients is obtained or the surgical indication is for staging or prognostic information.

Axilla↗

The prevention of emesis in plastic surgery: a randomized, prospective study.

Perhaps the most unpleasant experience following outpatient plastic surgery procedures is postoperative nausea and vomiting. Postoperative nausea and vomiting often results in delayed recovery time and unintended admission, and it can be a contributing factor to the formation of hematoma following rhytidectomy. Ondansetron (Zofran) has proven benefit in preventing postoperative nausea and vomiting if given before general anesthesia in a variety of surgical procedures. Its utility in cases performed under conscious sedation has not been determined. The purpose of this study was (1) to test the ability of prophylactic ondansetron to prevent postoperative nausea and vomiting in plastic surgery cases performed under conscious sedation, and (2) to determine relative risk factors for postoperative nausea and vomiting and a selection policy for the administration of antiemetic prophylaxis. This was a prospective, randomized, double-blind study. One hundred twenty patients were enrolled after giving informed consent. Patients received a single dose of either placebo or ondansetron (4 mg intravenously) before administration of sedation. Sedation administration followed a standardized institutional protocol, using midazolam and fentanyl. Data were recorded from a series of three questionnaires: preoperatively, immediately postoperatively, and at the time of the first office return. Data were confirmed by means of telephone interview, chart analysis, and nursing documentation. Multivariate analysis was conducted. Nausea and emesis occurred with an overall frequency of 33 percent and 22 percent, respectively. Postoperative nausea and vomiting was associated with statistically longer recovery periods. The incidence of emesis was statistically higher among women, among those undergoing facial rejuvenation, and among those with a history of opioid-induced emesis or postoperative nausea and vomiting following a previous operation (p < 0.05). The incidence of postoperative nausea and vomiting paralleled increases in case duration; the incidence of emesis was zero in cases less than 90 minutes in duration. Ondansetron significantly reduced the incidence of emesis overall (placebo, 30 percent; ondansetron, 13 percent; p < 0.05). Postoperative perception of nausea was significantly lower among those who had received ondansetron (p < 0.05). These results confirm the efficacy of ondansetron for the prevention of postoperative nausea and vomiting in plastic surgery cases under conscious sedation. In those who are at increased risk, prophylaxis should be considered. Such risks include female gender, facial rejuvenation procedures, and a patient history of opioid-induced emesis or postoperative nausea and vomiting following a prior operation. The zero incidence of emesis in cases less than 90 minutes does not support the routine use of prophylaxis in such cases. Patient satisfaction in plastic surgery is derived from the overall subjective experience of the event as much as by the final result. By remaining attentive to patient concerns and optimizing perioperative care, we can improve the subjective experience for our patients.

Analgesics, Opioid↗

Prophylactic thyroidectomy in MEN 2A syndrome.

Genetic testing is the appropriate procedure in MEN 2A syndrome for the early diagnosis of medullary carcinoma even at a preclinical stage. Prophylactic total thyroidectomy represents the standard preventive and therapeutic surgical approach in the treatment of medullary thyroid carcinoma in MEN 2A syndrome. Our experience has confirmed the presence of CCH and medullary thyroid carcinoma even in clinically negative patients, in agreement with reports in the literature.

Adult↗

Preventing infection in open heart surgery.

The risks for infection following open heart surgery may be divided into three components: the environment, operating room personnel, and the patient. Critical appraisal of the available literature yields the following conclusions. First, the environment may result in fungal or bacterial contamination of the surgical wound or mucosal surfaces. However, it is infrequently possible to prove that such contamination causes infections. Second, personnel may contaminate the patients, but rarely do so. Third, the patient's endogenous flora is most often the source of infecting bacteria. Proper preoperative preparation and judicious use of prophylactic antibiotics minimize the risk of infection.

Anti-Bacterial Agents↗

[Prevention of suppurative complications considering the risk of their occurrence].

The efficacy of a mark-grading system for the prognosis of the occurrence of suppuration in acquired and congenital heart diseases is analyzed in this work. The mathematical relationship between the sum of marks of the risk and the probability of the occurrence of purulent complication is proved. On the grounds of the found phenomenon a group of patients with high risk of purulent complications, needing some supplementary prophylactic procedures, has been selected. A complex of medicamental and organizational measures has been devised, which ensured more than 1.5-fold decrease of the incidence of surgical infection in high risk patients following operations with extracorporeal circulation.

Cardiac Surgical Procedures↗

Assessment of a protocol for prophylactic antibiotics to prevent perioperative infection in urological surgery: a preliminary study.

BACKGROUND: The aim of the present study was to assess the usability and efficacy of our new protocol of prophylactic antibiotic use to prevent perioperative infection in urological surgery. METHODS: We prospectively investigated 339 cases of typical urological surgery in our department between April 2001 and March 2002 (group I). We classified surgical procedures into four categories by invasiveness and contamination levels: category A, clean less invasive or endoscopic surgery; category B, clean invasive or clean contaminated surgery; category C, urinary tract diversion using the intestine; and category D, infected surgery. Antibiotics were administrated intravenously according to our protocol: category A, first or second generation cephems or penicillins during the operative day only; category B, first and second generation cephems or penicillins for 3 days; and category C, second or third generation cephems for 4 days. Category D was excluded from the analysis. To judge perioperative infections, the wound condition and general conditions were evaluated in terms of the surgical site infection (SSI) as well as remote infection (RI) up to postoperative day (POD) 14. We retrospectively reviewed 308 patients who underwent urological surgery between April 2000 and March 2001 (group II) as reference cases that were administered antibiotics without any restriction. RESULTS: Perioperative infection rates (SSI + RI) in group I and group II were 25 of 339 (7.4%) and 35 of 308 (11.4%), respectively. Surgical site infection rates of categories A, B, and C in group I were 1.8%, 7.6%, and 30.0%, respectively, while those in group II were 2.0%, 7.4%, and 46.2%, respectively. There was no significant difference in infection rates in terms of RI and SSI between group I and group II. The amounts, as well as the prices, for intravenously administrated antibiotics and oral antibiotics decreased to approximately half and one-fifth, respectively. CONCLUSION: Our protocol effectively decreased the amount of antibiotics used without increasing perioperative infection rates. Thus, our protocol of prophylactic antibiotic therapy would be recommended as an appropriate method for preventing perioperative infection in urological surgery.

Adolescent↗

Should antibiotic prophylaxis be used routinely in clean surgical procedures: a tentative yes.

BACKGROUND: The incidence of surgical site infection (SSI) after clean surgical procedure has traditionally been regarded as too low for routine antibiotic prophylaxis. But we now know that host factors may increase the risk of SSI to as high as 20%. We assessed the value of prophylactic cefotaxime in patients stratified for risk of SSI in a randomized double-blind trial. METHODS: Patients admitted for clean elective operations were enrolled, stratified for risk by National Nosocomial Infection Survey criteria, and randomized to receive intravenous cefotaxime 2 gm or placebo on call for operation. They were followed for 4 to 6 weeks for SSI diagnosed by Centers for Disease Control and Prevention criteria. RESULTS: Analysis of 775 patients showed that the 378 evaluable patients who received cefotaxime had 70% fewer SSI than those who did not--Mantel-Haenszel risk ratio (MH-RR) 0.31; 95% confidence intervals (CI) 0.11 to 0.83. Benefit was clear in the 616 low risk patients--0.97% versus 3.9% SSI (MH-RR 0.25, CI 0.07 to 0.87, p = 0.018), but only a trend was seen in 136 high risk patients--2.8% versus 6.1% SSI (MH-RR 0.48, CI 0.09 to 2.5). CONCLUSIONS: The results indicate clear benefit for routine antibiotic prophylaxis in clean surgical procedures. High risk patients need more study.

Adult↗

Perioperative management of rheumatoid arthritis. Areas of concern for primary care physicians.

The presence of rheumatoid arthritis can impose increased risks on patients undergoing surgical procedures. Affected patients often have peripheral joint inflammation, temporomandibular joint disease, laryngeal involvement, or cervical spine disease. Preoperative evaluation should also include assessment of cardiovascular disease, pulmonary disorders, and Sjögren's syndrome. Perioperative control of infection and prophylactic use of antibiotics are particularly important. To avoid wound-healing problems, preoperative discontinuation of therapy with aspirin, nonsteroidal anti-inflammatory drugs, and some slow-acting antirheumatic agents may be necessary. Effective management requires a team approach involving the primary care physician, the surgeon, other subspecialists, and allied healthcare personnel. To prevent unnecessary delays once the patient is hospitalized, preoperative assessment should be done primarily on an outpatient basis.

Antirheumatic Agents↗

Heterotopic bone in hip arthroplasties. Cemented versus noncemented.

Sixty-six hip arthroplasties in 55 patients were reviewed to specifically study cemented versus noncemented procedures, as related to heterotopic bone formation (HBF). Other factors considered included the type of arthroplasty, surgical approaches, preoperative and postoperative medicines, preoperative predisposing diagnoses, range of motion, and pain. The overall percentage of heterotopic ossification was 64%. There was no significant difference between cemented (67%) and noncemented (55%) procedures. Except for an increased percentage (80%) of ossification after a trochanteric osteotomy, there were no significant differences between the three reviewed surgical approaches. Male osteoarthritics had the highest overall HBF. Eighty percent of patients who previously had developed HBF also did so with a contralateral hip surgery. Surprisingly, all patients with gout (100%) developed HBF. Acetylsalicylic acid used prophylactically for anticoagulation had no significant effect. Resurfacing arthroplasty procedures accounted for half of the severe grades of HBF. A decreased range of motion occurred with more severe grades of HBF.

Age Factors↗

Care before and after laser skin resurfacing. A survey and review of the literature.

BACKGROUND: The extent of the wound healing period and the final outcome of cutaneous laser resurfacing are influenced not only by the treatment protocol and type of laser used but also on care of the skin before and after the procedure. OBJECTIVE: This project was conducted to determine the pre- and postresurfacing care protocols currently in practice and to research the literature in an effort to clarify which interventions can accelerate wound healing and improve efficacy of the treatment. METHODS: Three hundred thirty-nine questionnaires were mailed to all dermatology and plastic surgery members of the American Society for Laser Medicine and Surgery (ASLMS). Questionnaires were completed anonymously to decrease respondent bias. Statistical analysis included calculation of percentages and means of the data. RESULTS: Survey results are discussed and compared with data from the literature for the following interventions: tretinoin cream, glycolic acid cream, hydroquinone, oral prophylactic antibiotics, oral prophylactic antivirals, hydrogel dressings, semiocclusive ointments, topical antibiotics, topical corticosteroids, oral corticosteroids, and dilute acetic acid soaks. CONCLUSIONS: Many options are appropriate, based on data from past studies, for pre- and postresurfacing skin care. Approximately 73% of the results of the survey correlate with information from the literature. Past studies do provide information to help us select interventions that can improve wound healing and the final cosmetic outcome. Further studies involving resurfacing patients may clarify some of the more complex wound care issues, such as oral prophylactic antibiotics, hydroquinone, and topical vitamins C and E.

Data Collection↗

Prophylactic antibiotics for surgery.

This article discusses the determination of surgical patients to be given antibiotic prophylaxis. In addition, current concepts regarding selection of antibiotic prophylaxis necessary for a variety of surgical procedures are reviewed.

Anti-Bacterial Agents↗

Quality of life after prophylactic colectomy and ileorectal anastomosis in patients with familial adenomatous polyposis.

BACKGROUND: Prophylactic colectomy or proctocolectomy is standard treatment for colorectal manifestation of familial adenomatous polyposis (FAP), a dominantly inherited disorder for which the risk of developing colorectal cancer in an untreated patient is close to 100 percent. Hereditary nonpolyposis colorectal cancer (HNPCC) is also dominantly inherited but has a lower risk of colorectal cancer than FAP and does not have a clinically obvious phenotype. The role of prophylactic colectomy in patients with HNPCC is controversial. PURPOSE: This study was performed to examine the outcome of colectomy and ileorectal anastomosis (IRA) so its use as a prophylactic procedure can be better evaluated. METHODS: Records of all patients undergoing IRA for FAP between 1985 and 1993 were reviewed. Demographic data and data about the operation were collected. Surgical outcome data included length of hospital stay, complications, bowel function, quality of life, and patient satisfaction. RESULTS: There were 51 patients with a median age of 28 years; 24 were male. All but eight patients were asymptomatic, and all had less than 1,000 polyps in the resected specimen. Mean surgery time was 3.5 hours, mean blood loss was 406 ml, and median length of hospital stay was seven days. There were no deaths, and eight patients (16 percent) had complications. Mean number of stools per day after median follow-up of 4.2 years was 3.6. Only 11 patients had nighttime stooling. Four patients reported seepage, 9 had some incontinence, and 16 had urgency. Quality of life, rated on a scale of 0 to 10, was 7 or above in 44 of 48 assessed patients. Quality of health was rated 7 or higher in all 48 patients, energy level was 7 or higher in 39 patients, and overall happiness with surgery was 7 or higher in 47 patients. CONCLUSIONS: Colectomy and IRA is a relatively safe operation that results in minimum disturbance of bowel function. Patient satisfaction is usually high. Prophylactic colectomy can be offered to HNPCC gene carriers with a greater understanding of the likely outcome of surgery.

Adenomatous Polyposis Coli↗

Changing patterns in the practice of carotid endarterectomy in a large metropolitan area.

Changes in the practice of carotid endarterectomy were studied by review of all endarterectomies performed in the greater Cincinnati area during 1980 and from July 1983 through June 1984. The number of operations rose from 431 to 750 (74% increase). The perioperative stroke rate fell from 8.6% in 1980 to 5.1% in 1983-1984; operative mortality declined from 2.8% to 2.3%; and the combined stroke or death rate declined from 9.5% to 6.5%. Asymptomatic carotid artery disease was the indication for 50% of the endarterectomies during both time periods. The combined stroke or death rate for asymptomatic patients declined from 6.9% to 5.3%, but both rates were higher than the 3% suggested as acceptable for prophylactic carotid endarterectomy. We conclude that carotid endarterectomy is becoming an increasingly common procedure, that morbidity continues to decline, and that mortality continues to be significant. Citywide surgical morbidity and mortality remain excessive for patients with asymptomatic carotid disease.

Aged↗

Orthopaedic surgery on the HIV-positive patient: complications and outcome.

Orthopaedic surgeons practicing in areas with high prevalence of HIV-infected individuals may anticipate that up to 10% of their emergent cases and a highly variable percentage of elective cases will be HIV-positive. Basic science studies have demonstrated impairment of defenses to routine orthopaedic pathogens as well as opportunistic organisms. Clinical studies show that this impairment has not resulted in an increased incidence of postoperative infections or failure of wound healing in the asymptomatic HIV-positive patient. Current medical management seems adequate to prevent increased risk of early postoperative infection in the symptomatic HIV-positive patient undergoing orthopaedic procedures. The HIV-positive patient with a prosthetic implant may be at increased risk of late hematogenous implant infection as host defenses diminish. Regular medical attention, prophylactic antibiotics before dental work and any invasive procedures, and early evaluation and treatment of possible infections are especially important in this group. Because the risk of surgical complications increases with progression of the disease, guidelines for elective surgery should include an assessment of the HIV-positive patient's immune status. The CD4 cell count, history of opportunistic infection, serum albumen, skin anergy, and state of nutrition and general health probably provide the best information regarding the risk of postoperative complications. Based on current knowledge, orthopaedic surgeons should develop a general philosophy or guideline for elective and emergent surgery on the HIV-positive patient in various stages of disease.

AIDS-Related Opportunistic Infections↗

Management of immune thrombocytopenic purpura associated with the antiphospholipid antibody syndrome.

Our two patients had "primary" antiphospholipid antibody syndrome without underlying systemic lupus erythematosus or other systemic autoimmune process, as well as symptomatic immune thrombocytopenic purpura (ITP). The thrombocytopenia did not respond to prolonged courses of corticosteroids and/or immune globulin infusions, but was controlled following splenectomy. The presence of serum antibodies to platelet surface glycoproteins, typical of ITP, could be helpful in the confirmation of both of these disorders in the same patient, rather than secondary thrombocytopenia. Management of such cases is confounded by an increased risk for both bleeding and thrombosis, including fetal death. To reduce the risk of fetal loss and thrombosis, both patients were advised to take aspirin 80 mg daily. The frequency and clinical significance of this association would suggest that patients with ITP should be tested for antiphospholipid antibodies, particularly before pregnancy or surgical procedures. Patients with coexistent antiphospholipid antibody syndrome would be at increased risk for thrombosis in the post-operative period following splenectomy and should be given prophylactic anticoagulation.

Adrenal Cortex Hormones↗

Prophylactic portal nondecompression surgery in patients with esophageal varices. An interim report.

This is an interim report of a prospective controlled study to evaluate prophylactic surgery in 112 patients with portal hypertension and esophageal varices treated since 1980. Methods of operation were confined to those with the least influence on portal circulation, namely selective shunts and nonshunting direct interruption procedures. The bleeding rates were 19.2% in the medical group and none in the surgical group (p less than 0.01). The mortality in the medical group in case of first bleeding was 50%. Operative mortality was 3.3%. There was no difference in the survival rate between the two groups at the time of 2 years follow-up. Prophylactic surgery led to a prevention of esophageal bleeding without any increase in the mortality rates.

Adult↗