Postoperative Wound Infection
Conditions
Keywords
Prevention, Antiseptic Preoperative Scrub, Postoperative Wound Infection
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.
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.
Interventions
Preoperative skin preparation with scrub and paint technique
DRUGPovidone-Iodine
preoperative skin preparation with scrub and paint technique
Sponsors
Michael E. DeBakey VA Medical Center
Medical College of Wisconsin
US Department of Veterans Affairs
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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
Participants by arm
| Arm | Count |
|---|---|
| Povidone-iodine Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine | 440 |
| Chlorhexidine-alcohol Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol | 409 |
| Total | 849 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 4 |
| Overall Study | Underwent clean surgical procedure | 13 | 12 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Povidone-iodine | Chlorhexidine-alcohol | Total |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 14.2 | 53.3 years STANDARD_DEVIATION 14.6 | 53.1 years STANDARD_DEVIATION 14.4 |
| Age, Customized <18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >18 years | 440 participants | 409 participants | 849 participants |
| Region of Enrollment United States | 440 participants | 409 participants | 849 participants |
| Sex: Female, Male Female | 194 Participants | 168 Participants | 362 Participants |
| Sex: Female, Male Male | 246 Participants | 241 Participants | 487 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 440 | 3 / 409 |
| serious Total, serious adverse events | 3 / 440 | 4 / 409 |
Outcome results
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.
Time frame: during surgery and within the 30 days post surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Povidone-Iodine | 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. | 16.1 Percentage of Post Operative Infections |
| Chlorhexidine-Alcohol | 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. | 9.5 Percentage of Post Operative Infections |
Comparison: 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.p-value: 0.00495% CI: [0.41, 0.85]Log Rank