Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: povidone-iodine preoperative skin preparation with povidone-iodine |
Drug: Povidone-Iodine
preoperative skin preparation with scrub and paint technique
Other Names:
|
| Experimental: chlorhexidine-alcohol preoperative skin preparation with scrub and paint technique |
Drug: chlorhexidine-alcohol
Preoperative skin preparation with scrub and paint technique
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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. [during surgery and within the 30 days post surgery]
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.
Eligibility Criteria
Criteria
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.
-
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.
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Veterans Affairs Boston Healthcare System | West Roxbury | Massachusetts | United States | 02132 |
| 2 | Durham VA Medical Center | Durham | North Carolina | United States | 27705 |
| 3 | Ben Taub General Hospital | Houston | Texas | United States | 77030 |
| 4 | Michael E Debakey Medical Center | Houston | Texas | United States | 77030 |
| 5 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53214 |
| 6 | Milwaukee VA Medical Center | Milwaukee | Wisconsin | United States | 53214 |
Sponsors and Collaborators
- Baylor College of Medicine
- Michael E. DeBakey VA Medical Center
- Medical College of Wisconsin
- US Department of Veterans Affairs
Investigators
- Study Chair: Rabih O Darouiche, M.D., Baylor College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-14542
Study Results
Participant Flow
| Recruitment Details | 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 |
|---|---|
| Pre-assignment Detail | 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 |
| Arm/Group Title | Povidone-Iodine | Chlorhexidine-Alcohol |
|---|---|---|
| Arm/Group Description | Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine | Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol |
| Period Title: Overall Study | ||
| STARTED | 440 | 409 |
| COMPLETED | 422 | 391 |
| NOT COMPLETED | 18 | 18 |
Baseline Characteristics
| Arm/Group Title | Povidone-iodine | Chlorhexidine-alcohol | Total |
|---|---|---|---|
| Arm/Group Description | Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine | Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol | Total of all reporting groups |
| Overall Participants | 440 | 409 | 849 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
52.9
(14.2)
|
53.3
(14.6)
|
53.1
(14.4)
|
| Age, Customized (participants) [Number] | |||
| <18 years |
0
0%
|
0
0%
|
0
0%
|
| >18 years |
440
100%
|
409
100%
|
849
100%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
194
44.1%
|
168
41.1%
|
362
42.6%
|
| Male |
246
55.9%
|
241
58.9%
|
487
57.4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
440
100%
|
409
100%
|
849
100%
|
Outcome Measures
| Title | 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. |
|---|---|
| Description | 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. |
| Time Frame | during surgery and within the 30 days post surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Povidone-Iodine | Chlorhexidine-Alcohol |
|---|---|---|
| Arm/Group Description | Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine | Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol |
| Measure Participants | 440 | 409 |
| Number [Percentage of Post Operative Infections] |
16.1
|
9.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Povidone-Iodine, Chlorhexidine-Alcohol |
|---|---|---|
| Comments | The average baseline rate of surgical-site infection at the six participating hospitals was 14% after clean-contaminated surgery with povidone-iodine skin preparation, and we estimated that substituting chlorhexidine-alcohol for povidone-iodine would reduce this rate to 7%. Therefore, we planned to enroll approximately 430 patients in each study group who could be evaluated in order for the study to have 90% power to detect a significant difference in the rates of surgical-site infection. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Relative Risk |
| Estimated Value | 0.59 | |
| Confidence Interval |
(2-Sided) 95% 0.41 to 0.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Povidone-Iodine | Chlorhexidine-Alcohol | ||
| Arm/Group Description | Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine | Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol | ||
All Cause Mortality |
||||
| Povidone-Iodine | Chlorhexidine-Alcohol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Povidone-Iodine | Chlorhexidine-Alcohol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/440 (0.7%) | 4/409 (1%) | ||
| Surgical and medical procedures | ||||
| Death | 3/440 (0.7%) | 3 | 4/409 (1%) | 4 |
Other (Not Including Serious) Adverse Events |
||||
| Povidone-Iodine | Chlorhexidine-Alcohol | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/440 (0.7%) | 3/409 (0.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Pruritis/Erythema | 3/440 (0.7%) | 3 | 3/409 (0.7%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Rabih Darouiche, M.D. |
|---|---|
| Organization | Baylor College of Medicine |
| Phone | 713-794-8858 |
| rabihd@bcm.edu |
- H-14542