human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The necessary duration of antibiotic administration after open fracture has not been established . In a double-blind prospect i ve trial we r and omized 248 patients with open fractures to receive one or five days of cefonicid sodium therapy or five days of cefam and ole nafate therapy as part of the initial treatment . Rates of fracture-associated infections in the three groups were ten ( 13 % ) of 79 , ten ( 12 % ) of 85 , and 11 ( 13 % ) of 84 , respectively . The 95 % confidence limit for the difference in infection rates between the one-day group and the combined five-day groups was 0 % to 8.3 % . The actual difference was 0.2 % . A brief course of antibiotic administration is not inferior to a prolonged course of antibiotics for prevention of postoperative fracture-site infections Background The optimal antibiotic regimen is still controversial in open fractures . The purpose of this study was to evaluate the efficacy of two different antibiotic regimens in management of type III-A open fractures . Methods From January 2001 to January 2008 , patients with type IIIA open fractures admitted in Shahid Beheshti Hospital Affiliated to Babol University of Medical Sciences were enrolled . Patients r and omly received cefazolin plus gentamicin ( group I ) or cefazolin plus ciprofloxacin ( group II ) . Both regimens were administered for 3 days . All patients were followed for 3 months . The efficacy of both regimens was compared . Results One hundred-forty eight and 153 patients were treated in group I and II , respectively . The mean age of the patients treated in group I was 36.96±14.4 and in group II was 36.93±13.51 years .  The rate of deep infection in group I was 5.4 % and in group II was 6.5 % . The efficacy of regimen I was 94.6 % and regimen II was 93.5 % . Conclusion Cefazolin plus gentamicin , or cefazolin plus ciprofloxacin both can be successfully used for prevention of infection in type IIIA open fractures In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias OBJECTIVE The purpose of this study was to compare the efficacy of a single agent , ciprofloxacin , with that of combination antibiotic therapy consisting of cefam and ole and gentamicin in all types of open fracture wounds . STUDY DESIGN A prospect i ve double-blind r and omized clinical trial . SETTING A Level 1 trauma center . PATIENTS One hundred ninety-five consecutive patients with 203 open fractures were enrolled over a twenty-month period . Twenty-nine fractures from low-velocity gunshot wounds were excluded , and three other patients were excluded because of protocol violations . Our final number of patients were 163 , with 171 open fractures . MAIN OUTCOME MEASUREMENT The infection rates for Type I and Type II open fractures for both antibiotic groups were calculated . The infection rate of Type III open fractures for both antibiotic groups was also calculated . Chi-square analysis with Yates correction was used to assess statistical significance of two treatment groups . RESULTS The infection rate for Types I and II open fractures in the ciprofloxacin group was 5.8 percent and 6 percent for the cefam and ole/gentamicin group ( p = 1.000 ) . The infection rate for Type III open fractures for the ciprofloxacin group was 31 percent ( 8 of 26 ) versus 7.7 percent ( 2 of 26 ) for the cefam and ole/gentamicin group ( p = 0.079 ) . There were no statistically significant differences in infection rate between the group treated with ciprofloxacin and that treated with cefam and ole/gentamicin for Types I and II open fracture wounds . However , there appeared to be a high failure rate for the ciprofloxacin Type III open fracture group , with patients being 5.33 times more likely to become infected than those in the combination therapy group . Although this difference was not statistically significant , possibly because of the small sample size , there was a definite trend toward statistical significance . CONCLUSION Single-agent antibiotic therapy with ciprofloxacin is effective in treatment of Type I and Type II open fracture wounds . However , on the basis of our results , we can not recommend ciprofloxacin alone for Type III wounds . Possibly one can use fluoroquinolones in combination therapy , specifically as an alternate to an aminoglycoside In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies , most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted Systematic review s and meta-analyses published in recent years have allowed drafting of evidence -based guidelines for antibiotic prophylaxis in orthopedic and trauma surgery . It is important to recognize the limitations of the recommendations derived from the available body of evidence . Since some of the most relevant r and omized controlled clinical trials were performed more than 20 years ago , it is sometimes difficult to apply the data to today 's clinical practice . In establishing consensus guidelines , it could prove difficult to identify areas for improvement through further research and better compliance . Although recommendations for optimized treatment of orthopedic implant infections are not currently based on first-class evidence , there are very promising new concepts emerging in this field , and we are awaiting more data and decisive conclusions from larger clinical trials Abstract In a r and omised double-blind trial conducted between 1990 and 1994 , 616 patients from 43 centres , pefloxacin ( group P , 316 patients ) and a cefazolin-oxacillin combination ( group C , 300 patients ) were compared in the prophylaxis of bone infection after grade 1 and 2 open leg fractures . Sample s were obtained at emergency , before and during surgery , and from drain aspirates . Antimicrobial susceptibility , slime production and adherence properties of the bacteria were tested . Cultures at emergency and before surgery showed similar distributions of gram-positive and gram-negative bacteria in both groups , while wound closure and infecting isolates showed prevailing gram-positive bacteria in group P and gram-negative bacteria in group C. Positive cultures at each stage were correlated with the occurrence of infection but were not predictive of the infecting species , which were nosocomial bacteria in most cases . Positive cultures at wound closure warn of a higher infection risk . Twenty-one of 316 ( 6.6 % ) patients in group P and 24 of 300 ( 8 % ) in group C were considered infected within 3 months . The difference is not significant ( chi-square test = 0.42;P=0.51 ) . Infecting strains were isolated from 38 patients ( group P , 18 ; group C , 20 ) . Infecting species , although not predictable , appear to be those escaping the spectrum of the prescribed antimicrobial prophylaxis Objective : To develop preliminary data on Staphylococcus aureus colonization and surgical site infections ( SSIs ) in patients with open fractures who received st and ard antibiotic prophylaxis  compared with a regimen including targeted methicillin-resistant Staphylococcus aureus ( MRSA ) coverage . Design : R and omized prospect i ve clinical trial . Patients : Adult patients who presented to the emergency department with an open fracture between April 2009 and July 2011 . Interventions : One hundred thirty patients were r and omized to receive prophylaxis with either cefazolin alone ( control arm ) or vancomycin and cefazolin ( experimental arm ) from presentation to the emergency department until 24 hours after the surgical intervention . Screening for S. aureus carriage was performed with nares swabs and predebridement and postdebridement open fracture wound swabs . Patients underwent prospect i ve assessment for the development of SSI for no less than 30 days and up to 12 months . Results : Nasal colonization of methicillin-sensitive S. aureus and MRSA among the sample was 20 % and 3 % , respectively . No significant difference in the rates of SSI was observed between the study arms ( 15 % vs 19 % , respectively , P = 0.62 ) . Staphylococcus aureus caused 55 % of the deep incisional/organ space SSI , with 18 % attributed to MRSA . A significantly higher rate of MRSA SSIs was observed among MRSA carriers compared with noncarriers ( 33 % vs 1 % , respectively , P = 0.003 ) . Conclusions : Staphylococcus aureus nasal colonization in trauma patients with open fractures is similar to that of the general community . In this pilot study , the addition of vancomycin to st and ard antibiotic prophylaxis was found safe , but its efficacy should be evaluated in a larger multiinstitutional trial . Level of Evidence : Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence This article introduces the approach of GRADE to rating  quality of evidence .  GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence This study compared the efficacy of antibiotic impregnated beads with conventional intravenous antibiotics in the treatment of open fractures . A r and omized prospect i ve study was design ed and conducted during a 29-month period . Sixty-seven patients with 75 open fractures were treated similarly , with the exception of the method of antibiotic administration , and were followed up for at least 1 year after injury . Infection occurred in two of 24 ( 8.3 % ) fractures treated with antibiotic beads alone and in two of 38 ( 5.3 % ) fractures treated with conventional intravenous antibiotics . In an unanticipated nonr and omized third cohort group , patients received antibiotic beads and intravenous antibiotics administered for nonorthopaedic reasons or limb threatening injury , or both . Two of 13 ( 15.4 % ) fractures in this high risk group became infected . Infection ultimately resolved in all fractures treated with antibiotic beads alone or antibiotic beads in conjunction with conventional intravenous antibiotics . This study was unable to achieve statistical significance ; however , the data suggest antibiotic beads may be useful in preventing infection in open fractures . Thus , a larger multicenter r and omized prospect i ve study of isolated open fractures , eliminating other variables , is justified BACKGROUND Open fractures are an important source of morbidity and are associated with delayed union , nonunion , and infection . Preventing infection through meticulous irrigation and debridement is an important goal in management , and different lavage fluids and irrigation techniques ( e.g. , high- or low-pressure lavage ) have been described for this purpose . However , there are a limited number of r and omized trials comparing irrigating solutions or irrigating technique . We compared the use of castile soap versus normal saline and high- versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds . METHODS We conducted a multicenter , blinded , r and omized 2 × 2 factorial pilot 
    Output:
    
agent
Results of r and omized controlled trials performed to date provide evidence that antibiotic prophylaxis reduces subsequent infection and that courses as short as one day are as effective as courses of three to five days , although the evidence warrants only low to moderate confidence .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The necessary duration of antibiotic administration after open fracture has not been established . In a double-blind prospect i ve trial we r and omized 248 patients with open fractures to receive one or five days of cefonicid sodium therapy or five days of cefam and ole nafate therapy as part of the initial treatment . Rates of fracture-associated infections in the three groups were ten ( 13 % ) of 79 , ten ( 12 % ) of 85 , and 11 ( 13 % ) of 84 , respectively . The 95 % confidence limit for the difference in infection rates between the one-day group and the combined five-day groups was 0 % to 8.3 % . The actual difference was 0.2 % . A brief course of antibiotic administration is not inferior to a prolonged course of antibiotics for prevention of postoperative fracture-site infections Background The optimal antibiotic regimen is still controversial in open fractures . The purpose of this study was to evaluate the efficacy of two different antibiotic regimens in management of type III-A open fractures . Methods From January 2001 to January 2008 , patients with type IIIA open fractures admitted in Shahid Beheshti Hospital Affiliated to Babol University of Medical Sciences were enrolled . Patients r and omly received cefazolin plus gentamicin ( group I ) or cefazolin plus ciprofloxacin ( group II ) . Both regimens were administered for 3 days . All patients were followed for 3 months . The efficacy of both regimens was compared . Results One hundred-forty eight and 153 patients were treated in group I and II , respectively . The mean age of the patients treated in group I was 36.96±14.4 and in group II was 36.93±13.51 years .  The rate of deep infection in group I was 5.4 % and in group II was 6.5 % . The efficacy of regimen I was 94.6 % and regimen II was 93.5 % . Conclusion Cefazolin plus gentamicin , or cefazolin plus ciprofloxacin both can be successfully used for prevention of infection in type IIIA open fractures In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias OBJECTIVE The purpose of this study was to compare the efficacy of a single agent , ciprofloxacin , with that of combination antibiotic therapy consisting of cefam and ole and gentamicin in all types of open fracture wounds . STUDY DESIGN A prospect i ve double-blind r and omized clinical trial . SETTING A Level 1 trauma center . PATIENTS One hundred ninety-five consecutive patients with 203 open fractures were enrolled over a twenty-month period . Twenty-nine fractures from low-velocity gunshot wounds were excluded , and three other patients were excluded because of protocol violations . Our final number of patients were 163 , with 171 open fractures . MAIN OUTCOME MEASUREMENT The infection rates for Type I and Type II open fractures for both antibiotic groups were calculated . The infection rate of Type III open fractures for both antibiotic groups was also calculated . Chi-square analysis with Yates correction was used to assess statistical significance of two treatment groups . RESULTS The infection rate for Types I and II open fractures in the ciprofloxacin group was 5.8 percent and 6 percent for the cefam and ole/gentamicin group ( p = 1.000 ) . The infection rate for Type III open fractures for the ciprofloxacin group was 31 percent ( 8 of 26 ) versus 7.7 percent ( 2 of 26 ) for the cefam and ole/gentamicin group ( p = 0.079 ) . There were no statistically significant differences in infection rate between the group treated with ciprofloxacin and that treated with cefam and ole/gentamicin for Types I and II open fracture wounds . However , there appeared to be a high failure rate for the ciprofloxacin Type III open fracture group , with patients being 5.33 times more likely to become infected than those in the combination therapy group . Although this difference was not statistically significant , possibly because of the small sample size , there was a definite trend toward statistical significance . CONCLUSION Single-agent antibiotic therapy with ciprofloxacin is effective in treatment of Type I and Type II open fracture wounds . However , on the basis of our results , we can not recommend ciprofloxacin alone for Type III wounds . Possibly one can use fluoroquinolones in combination therapy , specifically as an alternate to an aminoglycoside In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies , most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted Systematic review s and meta-analyses published in recent years have allowed drafting of evidence -based guidelines for antibiotic prophylaxis in orthopedic and trauma surgery . It is important to recognize the limitations of the recommendations derived from the available body of evidence . Since some of the most relevant r and omized controlled clinical trials were performed more than 20 years ago , it is sometimes difficult to apply the data to today 's clinical practice . In establishing consensus guidelines , it could prove difficult to identify areas for improvement through further research and better compliance . Although recommendations for optimized treatment of orthopedic implant infections are not currently based on first-class evidence , there are very promising new concepts emerging in this field , and we are awaiting more data and decisive conclusions from larger clinical trials Abstract In a r and omised double-blind trial conducted between 1990 and 1994 , 616 patients from 43 centres , pefloxacin ( group P , 316 patients ) and a cefazolin-oxacillin combination ( group C , 300 patients ) were compared in the prophylaxis of bone infection after grade 1 and 2 open leg fractures . Sample s were obtained at emergency , before and during surgery , and from drain aspirates . Antimicrobial susceptibility , slime production and adherence properties of the bacteria were tested . Cultures at emergency and before surgery showed similar distributions of gram-positive and gram-negative bacteria in both groups , while wound closure and infecting isolates showed prevailing gram-positive bacteria in group P and gram-negative bacteria in group C. Positive cultures at each stage were correlated with the occurrence of infection but were not predictive of the infecting species , which were nosocomial bacteria in most cases . Positive cultures at wound closure warn of a higher infection risk . Twenty-one of 316 ( 6.6 % ) patients in group P and 24 of 300 ( 8 % ) in group C were considered infected within 3 months . The difference is not significant ( chi-square test = 0.42;P=0.51 ) . Infecting strains were isolated from 38 patients ( group P , 18 ; group C , 20 ) . Infecting species , although not predictable , appear to be those escaping the spectrum of the prescribed antimicrobial prophylaxis Objective : To develop preliminary data on Staphylococcus aureus colonization and surgical site infections ( SSIs ) in patients with open fractures who received st and ard antibiotic prophylaxis  compared with a regimen including targeted methicillin-resistant Staphylococcus aureus ( MRSA ) coverage . Design : R and omized prospect i ve clinical trial . Patients : Adult patients who presented to the emergency department with an open fracture between April 2009 and July 2011 . Interventions : One hundred thirty patients were r and omized to receive prophylaxis with either cefazolin alone ( control arm ) or vancomycin and cefazolin ( experimental arm ) from presentation to the emergency department until 24 hours after the surgical intervention . Screening for S. aureus carriage was performed with nares swabs and predebridement and postdebridement open fracture wound swabs . Patients underwent prospect i ve assessment for the development of SSI for no less than 30 days and up to 12 months . Results : Nasal colonization of methicillin-sensitive S. aureus and MRSA among the sample was 20 % and 3 % , respectively . No significant difference in the rates of SSI was observed between the study arms ( 15 % vs 19 % , respectively , P = 0.62 ) . Staphylococcus aureus caused 55 % of the deep incisional/organ space SSI , with 18 % attributed to MRSA . A significantly higher rate of MRSA SSIs was observed among MRSA carriers compared with noncarriers ( 33 % vs 1 % , respectively , P = 0.003 ) . Conclusions : Staphylococcus aureus nasal colonization in trauma patients with open fractures is similar to that of the general community . In this pilot study , the addition of vancomycin to st and ard antibiotic prophylaxis was found safe , but its efficacy should be evaluated in a larger multiinstitutional trial . Level of Evidence : Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence This article introduces the approach of GRADE to rating  quality of evidence .  GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence This study compared the efficacy of antibiotic impregnated beads with conventional intravenous antibiotics in the treatment of open fractures . A r and omized prospect i ve study was design ed and conducted during a 29-month period . Sixty-seven patients with 75 open fractures were treated similarly , with the exception of the method of antibiotic administration , and were followed up for at least 1 year after injury . Infection occurred in two of 24 ( 8.3 % ) fractures treated with antibiotic beads alone and in two of 38 ( 5.3 % ) fractures treated with conventional intravenous antibiotics . In an unanticipated nonr and omized third cohort group , patients received antibiotic beads and intravenous antibiotics administered for nonorthopaedic reasons or limb threatening injury , or both . Two of 13 ( 15.4 % ) fractures in this high risk group became infected . Infection ultimately resolved in all fractures treated with antibiotic beads alone or antibiotic beads in conjunction with conventional intravenous antibiotics . This study was unable to achieve statistical significance ; however , the data suggest antibiotic beads may be useful in preventing infection in open fractures . Thus , a larger multicenter r and omized prospect i ve study of isolated open fractures , eliminating other variables , is justified BACKGROUND Open fractures are an important source of morbidity and are associated with delayed union , nonunion , and infection . Preventing infection through meticulous irrigation and debridement is an important goal in management , and different lavage fluids and irrigation techniques ( e.g. , high- or low-pressure lavage ) have been described for this purpose . However , there are a limited number of r and omized trials comparing irrigating solutions or irrigating technique . We compared the use of castile soap versus normal saline and high- versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds . METHODS We conducted a multicenter , blinded , r and omized 2 × 2 factorial pilot 
    Output:
    