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| Name | Class |
|---|---|
| Michael E. DeBakey VA Medical Center | FED |
| Medical College of Wisconsin | OTHER |
| US Department of Veterans Affairs | FED |
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Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
This is a prospective, randomized, multicenter clinical trial. All adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| povidone-iodine | Active Comparator | preoperative skin preparation with povidone-iodine |
|
| chlorhexidine-alcohol | Experimental | preoperative skin preparation with scrub and paint technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chlorhexidine-alcohol | Drug | Preoperative skin preparation with scrub and paint technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds. | The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed. | during surgery and within the 30 days post surgery |
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Inclusion Criteria: Adult patients who are scheduled for a clean-contaminated surgical procedure of the alimentary or respiratory tract will be eligible for participation. A clean-contaminated wound is one that is entered under controlled conditions without unusual contamination.
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Exclusion Criteria: Patients will be excluded form the study if: (1) they are unable or unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine, alcohol or iodophors.
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| Name | Affiliation | Role |
|---|---|---|
| Rabih O Darouiche, M.D. | Baylor College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Boston Healthcare System | West Roxbury | Massachusetts | 02132 | United States | ||
| Durham VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20054046 | Derived | Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988. |
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There were no significant events prior to group assignment. Enrolled patients were immediately and randomly assigned in a 1:1 ratio to a study arm. To help match the two groups and address potential inter-hospital differences, randomization was stratified by hospital with the use of computer-generated randomization numbers without blocking
Patients 18 years or older undergoing clean-contaminated surgery preformed without substantial spillage or unusual contamination were eligible for enrollment. Patients were excluded if they were allergic to chlorhexidine, alcohol, or iodophors, or had infection at or adjacent to operative site, & if there was a perceived inability for a 30 days F/U
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| ID | Title | Description |
|---|---|---|
| FG000 | Povidone-Iodine | Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine |
| FG001 | Chlorhexidine-Alcohol | Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Povidone-Iodine | Drug | preoperative skin preparation with scrub and paint technique |
|
|
| Durham |
| North Carolina |
| 27705 |
| United States |
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
| Michael E Debakey Medical Center | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53214 | United States |
| Milwaukee VA Medical Center | Milwaukee | Wisconsin | 53214 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Povidone-iodine | Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine |
| BG001 | Chlorhexidine-alcohol | Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds. | The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed. | Posted | Number | Percentage of Post Operative Infections | during surgery and within the 30 days post surgery |
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|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Povidone-Iodine | Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine | 3 | 440 | 3 | 440 | ||
| EG001 | Chlorhexidine-Alcohol | Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol | 4 | 409 | 3 | 409 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Surgical and medical procedures | Systematic Assessment | Death was NOT judged to be related to the study drugs in either group. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritis/Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rabih Darouiche, M.D. | Baylor College of Medicine | 713-794-8858 | rabihd@bcm.edu |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D000431 | Ethanol |
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000438 | Alcohols |
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| >18 years |
|
| Male |
|